Chlorhexidine for Umbilical Cord Care: Selected Bibliography · Background: There is an increased...

Chlorhexidine for Umbilical Cord Care: Selected B Chlorhexidine Working Group

Chlorhexidine for Umbilical Cord Care: Selected Bibliography

Title: Willingness to pay for a 4% chlorhexidine (7.1% chlorhexidine digluconate) product for

umbilical cord care in rural Bangladesh: a contingency valuation study.

Authors: Coffey PS, Metzler M, Islam Z, Koehlmoos TP

Citation: BMC Int Health Hum Rights. 2013;13:44. http://www.ncbi.nlm.nih.gov/pubmed/24139384

Abstract: Background: Recent trials in Bangladesh, Nepal, and Pakistan have shown that chlorhexidine is an effective antiseptic for umbilical cord care compared to existing community-based cord care practices. Because of the aggregate reduction in neonatal mortality in these trials, interest is high in introducing a 7.1% chlorhexidine digluconate liquid or gel that delivers 4% chlorhexidine for umbilical cord care in Bangladesh and elsewhere. Methods: In 2010, we conducted a household survey applying a contingent valuation method with 1717 eligible couples (pregnant women or women with a first child younger than 6 months old, and their husbands) in the rural subdistricts of Abhoynagar and Mirsarai in Bangladesh to assess their willingness to pay for three types of umbilical cord care products at different price points. Each respondent was asked about willingness to pay prefixed prices for any one of three 7.1% chlorhexidine digluconate products: 1) a single-dose liquid, 2) a multi-dose liquid, or 3) a gel formulation. Each also reported the maximum price they were independently willing to pay for their selected product. We compared participant willingness-to-pay responses to the prefixed prices with their independently reported maximum prices for each type of the product separately. The comparison identified to what extent the respondents' positive responses to the prefixed prices matched their independently reported maximum prices. Results: This cross matching revealed that willingness to pay the prefixed prices was 41% for the single-dose liquid, 33% for the multi-dose liquid, and 31% for the gel formulation. Although the majority of the respondents were unwilling to pay the prefixed prices, all were willing to pay some amount and reported they could borrow money if necessary. Subsequent analysis of responses to the multi-dose liquid showed borrowing money would not be required if the unit price was Bangladeshi taka 15--25. Conclusions: A unit price of Bangladeshi taka 15--25 (US$0.21--0.35) for multi-dose 7.1% chlorhexidine digluconate liquid would be affordable to the primary target population in Bangladesh. Although a large market demand could be generated if the product were available at this price point, subsidization may be required to achieve optimal coverage, especially among poorer families.

Title: The effect of umbilical cord cleansing with chlorhexidine on omphalitis and neonatal mortality in community settings in developing countries: a meta-analysis.

Authors: Imdad A, Mullany LC, Baqui AH, El Arifeen S, Tielsch JM, Khatry SK, Shah R, Cousens S, Black RE, Bhutta ZA.

Citation: BMC Public Health 2013; 13(3):S15. http://www.biomedcentral.com/1471-2458/13/S3/S15

Abstract: Background: There is an increased risk of serious neonatal infection arising through exposure of the umbilical cord to invasive pathogen in home and facility births where hygienic practices are difficult to achieve. The World Health Organization currently recommends ‘dry cord care’ because of insufficient data in favor of or against topical application of an antiseptic. The primary

Fundamental reading (most recent chronological order)

Updated February 2014 of 23

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objective of this meta-analysis is to evaluate the effects of application of chlorhexidine (CHX) to the umbilical cord to children born in low income countries on cord infection (omphalitis) and neonatal mortality. Standardized guidelines of Child Health Epidemiology Reference Group (CHERG) were followed to generate estimates of effectiveness of topical chlorhexidine application to umbilical cord for prevention of sepsis specific mortality, for inclusion in the Lives Saved Tool (LiST). Methods: Systematic review and meta-analysis. Data sources included Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, PubMed, CINHAL and WHO international clinical trials registry. Only randomized trials were included. Studies of children in hospital settings were excluded. The comparison group received no application to the umbilical cord (dry cord care), no intervention, or a non-CHX intervention. Primary outcomes were omphalitis and all-cause neonatal mortality. Results: There were three cluster-randomised community trials (total participants 54,624) conducted in Nepal, Bangladesh and Pakistan that assessed impact of CHX application to the newborn umbilical cord for prevention of cord infection and mortality. Application of any CHX to the umbilical cord of the newborn led to a 23% reduction in all-cause neonatal mortality in the intervention group compared to control [RR 0.77, 95 % CI 0.63, 0.94; random effects model, I2=50 %]. The reduction in omphalitis ranged from 27 % to 56 % compared to control group depending on severity of infection. Based on CHERG rules, effect size for all-cause mortality was used for inclusion to LiST model as a proxy for sepsis specific mortality. Conclusions: Application of CHX to newborn umbilical cord can significantly reduce incidence of umbilical cord infection and all-cause mortality among home births in community settings. This inexpensive and simple intervention can save a significant number of newborn lives in developing countries.

Title: Chlorhexidine cleansing of the umbilical cord and separation time: a cluster-randomized trial.

Authors: Mullany LC, Shah R, El Arifeen S, Mannan I, Winch PJ, Hill A, Darmstadt GL, Baqui AH.

Citation: Pediatrics. 2013;131(4):708–715. http://www.ncbi.nlm.nih.gov/pubmed/23509175

Abstract: Objective: Cord cleansing with chlorhexidine reduces neonatal mortality. We aimed to quantify the impact of this intervention on cord separation time and the implications of such an increase on maternal and other caretaker’s acceptance of chlorhexidine in future scaled up programs. Methods: Between June 2007 and September 2009, 29 760 newborns were randomly assigned within communities in Bangladesh to receive 1 of 3 cord regimens: dry and clean cord care (comparison), single-cleansing, or multiple-cleansing with 4.0% chlorhexidine. Workers recorded separation status during home visits. Mothers of 380 infants in randomly selected clusters reported age at separation and satisfaction with cord regimen. Results: Compared with dry and clean care (mean 4.78 days), separation time was longer in the single (mean 6.90 days, difference = 2.10; 95% confidence interval: 1.85-2.35) and multiple (mean 7.49 days, difference = 2.69; 95% confidence interval: 2.44-2.95) cleansing groups. Increased separation time was not associated with omphalitis. Mothers in these groups more frequently reported “longer than usual” separation times and dissatisfaction with the separation time (11.1% and 17.6%, respectively) versus the comparison group (2.5%). Overall satisfaction with the received cord care regimen was high (96.2%). Conclusions: Topical chlorhexidine increased cord separation time by ∼50%. Caretakers are likely to detect this increase and might express dissatisfaction but still accept the intervention overall. When scaling up chlorhexidine cord cleansing, inclusion of appropriate messaging on expectation and nonrisks of increased cord separation time, in addition to the benefits of reduced infection and improved survival, might improve compliance.

Title: Effect of topical application of chlorhexidine for umbilical cord care in comparison with conventional dry cord care on the risk of neonatal sepsis: a randomized controlled trial.




Authors: Gathwala G, Sharma D, Bhakhri BK.

Citation: J Trop Pediatr. 2013;59(3):209-213. http://www.ncbi.nlm.nih.gov/pubmed/23407285

Abstract: Aim: To compare topical application of chlorhexidine for umbilical cord care with conventional dry care for prevention of neonatal sepsis in neonatal intensive care unit (NICU). Methods: The study was conducted in the NICU of a teaching hospital in north India between 2010 and 2011. Newborns (≥32 weeks of gestation and weighing ≥1500 g) were randomized into chlorhexidine application and dry care groups. Data regarding time of cord separation, umbilical sepsis and neonatal sepsis were recorded. Results: One hundred forty (dry care group 70, chlorhexidine group 70) were enrolled and finally analysed. A significant difference was observed among groups in terms of time to cord separation and incidence of blood culture-proven sepsis though there was no statistical difference noted among the groups with regards to umbilical infection, probable sepsis and meningitis. Conclusion: Use of chlorhexidine for umbilical cord care prevents sepsis in the NICU.

Title: Topical umbilical cord care for prevention of infection and neonatal mortality.

Authors: Karumbi J, Mulaku M, Aluvaala J, English M, Opiyo N.

Citation: Pediatr Infect Dis J. 2013;32(1):78–83. http://www.ncbi.nlm.nih.gov/pubmed/23076382

Abstract: Umbilical cord care varies often reflecting community or health-worker beliefs. We undertook a review of current evidence on topical umbilical cord care. Study quality was assessed using the Grading of Recommendations, Assessment, Development and Evaluation system, and a meta-analysis was conducted for comparable trials. Available moderate-quality to high-quality evidence indicate that cord cleansing with 4% chlorhexidine may reduce the risk of neonatal mortality and sepsis (omphalitis) in low-resource settings.

Title: Chlorhexidine for umbilical cord care: game-changer for newborn survival?

Authors: Hodgins S, Pradhan YV, Khanal L, Upreti S, Pratap KCN.

Citation: Glob Health Sci Pract. 2013;1(1):5-10. http://www.ghspjournal.org/content/1/1/5.full.pdf+html

Abstract: A simple technology with potential to prevent 500,000 global neonatal deaths annually.

Title: A review of studies with chlorhexidine applied directly to the umbilical cord.

Authors: Goldenberg RL, McClure EM, Saleem S.

Citation: Am J Perinatol. 2012;30(8):699-701). http://www.ncbi.nlm.nih.gov/pubmed/23254380

Abstract: Infection-related neonatal mortality due to omphalitis in developing country home births is an important public health problem. Three cluster randomized trials of 4% chlorhexidine applied to the umbilical cord stump from once to multiple times in the days following a home birth have evaluated this intervention compared with other types of cord care on the development of omphalitis and neonatal mortality. Each of the three studies showed significant reductions in either omphalitis, neonatal mortality, or both with the 4% chlorhexidine. However, the optimal dosing schedule remains uncertain. Although further studies are needed to clarify this issue, from the three studies it is now clear that with a minimum of one application of 4% chlorhexidine to the umbilical cord stump following delivery, the incidence of omphalitis and neonatal




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mortality can be reduced, especially in preterm newborns. This intervention, which is safe and inexpensive and requires minimal training and skill, should strongly be considered for adoption wherever home births occur.

Title: The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial.

Authors: Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH.

Citation: Lancet. 2012;379(9820):1022–1028. http://www.ncbi.nlm.nih.gov/pubmed/22322124

Abstract: Background: Up to half of neonatal deaths in high mortality settings are due to infections, many of which can originate through the freshly cut umbilical cord stump. We aimed to assess the effectiveness of two cord-cleansing regimens with the promotion of dry cord care in the prevention of neonatal mortality. Design: We did a community-based, parallel cluster-randomised trial in Sylhet, Bangladesh. We divided the study area into 133 clusters, which were randomly assigned to one of the two chlorhexidine cleansing regimens (single cleansing as soon as possible after birth; daily cleansing for 7 days after birth) or promotion of dry cord care. Randomisation was done by use of a computer-generated sequence, stratified by cluster-specific participation in a previous trial. All livebirths were eligible; those visited within 7 days by a local female village health worker trained to deliver the cord care intervention were enrolled. We did not mask study workers and participants to the study interventions. Our primary outcome was neonatal mortality (within 28 days of birth) per 1000 livebirths, which we analysed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00434408. Results: Between June, 2007, and September, 2009, we enrolled 29 760 newborn babies (10 329, 9423, and 10 008 in the multiple-cleansing, single-cleansing, and dry cord care groups, respectively). Neonatal mortality was lower in the single-cleansing group (22·5 per 1000 livebirths) than it was in the dry cord care group (28·3 per 1000 livebirths; relative risk [RR] 0·80 [95% CI] 0·65-0·98). Neonatal mortality in the multiple-cleansing group (26·6 per 1000 livebirths) was not statistically significantly lower than it was in the dry cord care group (RR 0·94 [0·78-1·14]). Compared with the dry cord care group, we recorded a statistically significant reduction in the occurrence of severe cord infection (redness with pus) in the multiple-cleansing group (risk per 1000 livebirths=4·2 vs risk per 1000 livebirths=1·2; RR 0·35 [0·15-0·81]) but not in the single-cleansing group (risk per 1000 livebirths=3·3; RR 0·77 [0·40-1·48]). Interpretation: Chlorhexidine cleansing of a neonate’s umbilical cord can save lives, but further studies are needed to establish the best frequency with which to deliver the intervention.

Title: Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial.

Authors: Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA.


Abstract: Background: Umbilical cord infection (omphalitis) is a risk factor for neonatal sepsis and mortality in low-resource settings where home deliveries are common. We aimed to assess the effect of umbilical-cord cleansing with 4% chlorhexidine (CHX) solution, with or without handwashing with antiseptic soap, on the incidence of omphalitis and neonatal mortality. Methods: We did a two-by-two factorial, cluster-randomised trial in Dadu, a rural area of Sindh province, Pakistan. Clusters were defined as the population covered by a functional traditional birth attendant (TBA),





and were randomly allocated to one of four groups (groups A to D) with a computer-generated random number sequence. Implementation and data collection teams were masked to allocation. Liveborn infants delivered by participating TBAs who received birth kits were eligible for enrolment in the study. One intervention comprised birth kits containing 4% CHX solution for application to the cord at birth by TBAs and once daily by family members for up to 14 days along with soap and educational messages promoting handwashing. One intervention was CHX solution only and another was handwashing only. Standard dry cord care was promoted in the control group. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. The trial is registered with ClinicalTrials.gov, number NCT00682006. Findings: 187 clusters were randomly allocated to one of the four study groups. Of 9741 newborn babies delivered by participating TBAs, factorial analysis indicated a reduction in risk of omphalitis with CHX application (risk ratio [RR]=0·58, 95% CI 0·41-0·82; p=0·002) but no evidence of an effect of handwashing (RR=0·83, 0·61-1·13; p=0·24). We recorded strong evidence of a reduction in neonatal mortality in neonates who received CHX cleansing (RR=0·62, 95 % CI 0·45-0·85; p=0·003) but no evidence of an effect of handwashing promotion on neonatal mortality (RR=1·08, 0·79-1·48; p=0·62). We recorded no serious adverse events. Interpretation: Application of 4% CHX to the umbilical cord was effective in reducing the risk of omphalitis and neonatal mortality in rural Pakistan. Provision of CHX in birth kits might be a useful strategy for the prevention of neonatal mortality in high-mortality settings.

Title: Impact of 4.0% chlorhexidine cord cleansing on the bacteriologic profile of the newborn umbilical stump in rural Sylhet District, Bangladesh: a community-based, cluster-randomized trial.

Authors: Mullany LC, Saha SK, Shah R, Islam MS, Rahman M, Islam M, Talukder RR, El Arifeen S, Darmstadt GL, Baqui AH.


Abstract: Background: Randomized trials from South Asia indicate umbilical cord chlorhexidine cleansing reduces mortality and omphalitis. No community-based data are available on bacteriological profile of the cord, early neonatal colonization dynamics, or impact of cord cleansing on colonizing organisms. Such data could clarify the design of scaled chlorhexidine interventions. Methods: Umbilical swabs were collected at home (days 1, 3, 6) after birth from infants participating in a trial of 3 cord-care regimens (no chlorhexidine, single cleansing, multiple cleansing) in Sylhet, Bangladesh. Overall and organism-specific positivity rates were estimated by cord-care regimen and by day of collection. Results: Between September 2008 and October 2009, 1923 infants contributed 5234 umbilical swabs. Positivity rate was high (4057 of 5234, 77.5%) and varied substantially across groups. Immediate (day 1) reductions in cord colonization were observed in single- (prevalence rate ratio = 0.75, 95% confidence interval: 0.70-0.81) and multiple- (prevalence rate ratio = 0.71, 95% confidence interval: 0.66-0.77) cleansing groups. Reductions persisted and increased in magnitude through day 6 only if babies received multiple applications. On days 1, 3, and 6, respectively, multiple cleansing consistently reduced invasive organisms such as Escherichia coli (49%, 64%, and 42% lower), Klebsiella pneumoniae (46%, 53%, and 33% lower), and Staphylococcus aureus (34%, 84%, and 85% lower). Conclusions: Cord cleansing with 4.0% chlorhexidine immediately after birth reduces overall and organism-specific colonization of the stump. Reductions are greater and sustained longer with daily cleansing through the first week of life, suggesting that programs promoting chlorhexidine cleansing should favor multiple over single applications.




Title: Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh.

Authors: Darmstadt GL, Choi Y, Arifeen SE, Bari S, Rahman SM, Mannan I, Seraji HR, Winch PJ, Saha SK, Ahmed AsMNU, Ahmend S, Begum N, Lee ACC, Black RE, Santosham M, Crook D, Baqui AH for Bangladesh Projahmo-2 (Mirzapur) Study Group.

Citation: PLoS One. 2010;5(3):e9696. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2844410/

Abstract: Background: To evaluate a delivery strategy for newborn interventions in rural Bangladesh. Methods: A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality. Findings: A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80–1.30) at baseline and 0.87 (95% CI: 0.68–1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported. Conclusion: Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management. Trial Registration: Clinicaltrials.gov (NCT00198627).

Title: Chlorhexidine gel versus aqueous for preventive use on umbilical stump: a randomized noninferiority trial.

Authors: Hodgins S, Thapa K, Khanal L, Aryal S, Suvedi BK, Baidya U, Mullany LC.


Abstract: Background: Recent trials of chlorhexidine cord cleansing have employed aqueous solution applied with cotton swabs. Care-takers may prefer gel, resulting in better compliance when implemented at large scale. We examined whether a guar-gum-thickened formulation was at least as efficacious as aqueous in reducing periumbilical flora. Methods: Newborns (n = 694) from normal deliveries at a hospital in Kathmandu were randomly allocated to cord cleansing with either gel or aqueous chlorhexidine, applied by finger. Immediately before and 24 hours after cleansing, periumbilical swabs were collected and cultured. The primary outcome was periumbilical colonization at 24 hours. Household-level acceptability and ease of use in a rural setting where most deliveries are not attended by health workers were assessed by providing 61 women with either gel or aqueous formulations and following up on their experience using the


http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2844410/

http://www.clinicaltrials.gov/ct2/show/NCT00198627



products. Results: Babies allocated to gel and aqueous chlorhexidine were comparable on a range of variables measured at baseline. At 24 hours post application, 4.6% (15 of 327) of cultures were positive in the gel group and 10.7% (35 of 326) in the aqueous group. The absolute difference in rates (gel minus aqueous) was -6.1% (95% CI: -10.2%, -2.1%). The acceptability study found that satisfaction and compliance were high for both; use of either largely displaced the traditional use of oil-based mixtures. Overall, there was a preference for gel. Conclusions: The gel formulation was not inferior to aqueous and gel reduced bacterial colonization to a greater degree. A gel formulation might be considered in future research or program settings where chlorhexidine cleansing of the cord is being evaluated or promoted.

Title: Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of community-based cluster randomized trial.

Authors: Mullany LC, Arifeen SE, Winch PJ, Shah R, Mannan I, Rahman SM, Rahman MR, Darmstadt GL, Ahmed S, Santosham M, Black RE, Baqui AH.

Citation: BMC Pediatr. 2009;9:67. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770449/

Abstract: Background: The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated that umbilical cord cleansing with 4.0% chlorhexidine could substantially reduce mortality and omphalitis risk, but policy changes await additional community-based data. Methods: The Projahnmo Chlorhexidine study was a three-year, cluster-randomized, community-based trial to assess the impact of three cord care regimens on neonatal mortality and omphalitis. Women were recruited mid-pregnancy, received a basic package of maternal and neonatal health promotion messages, and were followed to pregnancy outcome. Newborns were visited at home by local village-based workers whose areas were randomized to either 1) single- or 2) 7-day cord cleansing with 4.0% chlorhexidine, or 3) promotion of dry cord care as recommended by WHO. All mothers received basic messages regarding hand-washing, clean cord cutting, and avoidance of harmful home-base applications to the cord. Death within 28 days and omphalitis were the primary outcomes; these were monitored directly through home visits by community health workers on days 1, 3, 6, 9, 15, and 28 after birth. Discussion: Due to report in early 2010, the Projahnmo Chlorhexidine Study examines the impact of multiple or single chlorhexidine cleansing of the cord on neonatal mortality and omphalitis among newborns of rural Sylhet District, Bangladesh. The results of this trial will be interpreted in conjunction with a similarly designed trial previously conducted in Nepal, and will have implications for policy guidelines for optimal cord care of newborns in low resource settings in Asia. Trial Registration: ClinicalTrials.gov (NCT00434408).

Title: Risk of mortality subsequent to umbilical cord infection among newborns of Southern Nepal, cord infection and mortality.

Authors: Mullany LC, Darmstadt GL, Katz J, Khatry SK, LeClerq SC, Adhikari RK, Tielsch JM.

Citation: Pediatr Infect Dis J. 2009;28(1):17–20. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2680481/

Abstract: Background: Neonatal sepsis may stem from local umbilical cord infections. Signs of cord infection are common in low-resource settings, yet the risk of mortality subsequent to these signs has not been quantified in either developed or developing countries. We compared the risk of mortality between infants with and without signs of umbilical cord infection during a





community-based trial of chlorhexidine interventions in southern Nepal. Methods: Newborns were evaluated for signs of umbilical cord infection (pus, redness, swelling). A nested case-control approach was used to estimate the odds of mortality between infants with and without umbilical cord infection as defined by various levels of severity. For each death in the parent trial, 10 controls were selected, matched on sex, treatment group, and number of cord assessments. The main outcome measures were all-cause and sepsis-specific mortality. Results: Among 23,246 assessed infants, there were 392 deaths. Odds of all-cause mortality were 46% (8–98%) higher among infants with redness extending onto the abdominal skin. A nonsignificant increased odds of mortality [odds ratio (OR): 2.31; 95% confidence interval (CI): 0.66–8.10] was observed among infants with severe redness and pus. Infections occurring after the third day of life were associated with subsequent risk of all-cause (OR: 3.11; 95% CI: 1.68 –5.74) and sepsis-specific (OR: 4.63; 95% CI: 2.15–9.96) mortality. Conclusions: This study provides evidence that common local signs of cord infection are associated with increased risk of mortality. Where exposure of the umbilical cord to potentially invasive pathogens is high, interventions to increase hygienic care of the cord should be promoted and including hand washing, avoiding harmful topical applications, and topical cord antisepsis.

Title: Differentials in neonatal mortality in two adjacent rural areas of Bangladesh: Lessons for neonatal health interventions.

Authors: Baqui AH, Arifeen SE, Darmstadt GL, ahmed S, Seraji HR, Winch PJ, Williams EK, Santosham M, Black RE; the Bangladesh Projahnmo Study Group.

Citation: Global Public Health. 2008;3(4):366–382. http://www.tandfonline.com/doi/abs/10.1080/17441690701592866

Abstract: A household survey, conducted in three rural sub-districts of northeastern Bangladesh, revealed a markedly lower neonatal mortality rate (NMR) in one sub-district compared to two adjacent sub-districts. This study examines the degree to which the differential in NMR can be explained by factors that could be improved by maternal and newborn health programmes, such as knowledge of danger signs and use of antenatal, delivery, and postnatal care. Use of a skilled birth attendant in uncomplicated deliveries, mothers’ knowledge of newborn complications, and use of health care for sick newborns accounted for 32% of the differential in NMR. Pregnancy and delivery complications were associated with increased risk of neonatal mortality, and distance to nearest emergency obstetric care facility was significantly associated with lower risk of neonatal mortality. Therefore, health programmes to improve mothers’ knowledge of newborn complications, to increase access to emergency obstetric care, and to promote appropriate use of health care could significantly reduce neonatal mortality in impoverished communities.

Title: Developing community-based intervention strategies to save newborn lives: lessons learned from formative research in five countries.

Authors: Neonatal Mortality Formative Research Working Group.

Citation: J Perinatol. 2008;28 (2):S2–S8. http://www.ncbi.nlm.nih.gov/pubmed/19057564

Abstract: Paper summarizes lessons learned from formative research conducted in Bangladesh, Ghana, India, Mali and Nepal to inform the development of newborn health interventions, mostly in the context of field trials. Current practices, constraints to the adoption of optimal practices and implications for implementing inventions to improve newborn survival are discussed for: optimal


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care during pregnancy; skilled care at birth; optimal delivery and newborn care practices; special care of low birth weight babies; and timely and appropriate care seeking for newborn illness. General lessons concerning target audiences and intervention strategy are also drawn. In brief, interventions to reduce neonatal mortality need to start during pregnancy not only to promote birth preparedness and institutional delivery, but also to start the process of change concerning early newborn care practices. Their target audience should not only be pregnant or recently delivered women, but also include the main gatekeepers, particularly traditional birth attendants, grandmothers and other family members. Health providers’ opinions also matter as care practices are less likely to change if families receive conflicting messages from different sources. Interventions are more likely to succeed if they are not simply message based, but include problem solving approaches, and a behavior change component to address community norms. Although antenatal care (ANC) is theoretically a good channel for newborn interventions, capitalising on its potential is not straightforward, and will require considerable investment and intervention development in its own right in order to improve ANC counselling, which will need to extend beyond training and tackle the many working day constraints encountered by ANC providers. Removing or subsidising the cost of deliveries may be a necessary action to increase institutional deliveries, but it is unlikely to be sufficient; measures will need to be put in place to ensure the basic quality of institutional deliveries and newborn care, and to change staff attitudes and practices. Post-natal visits should include observation of the baby, referral and counselling of the mother concerning danger signs in addition to promoting optimal care practices. The lessons learned should guide the development of interventions in other contexts, and ensure that key essential elements are not overlooked. They do not, however, mean that formative research will not be needed in other contexts, although the list of questions to address should be considerably reduced; successful intervention strategies require adaptation to make them local, context-specific if they are to be effective, and ongoing process monitoring to ensure the quality of intervention delivery, to check that it is having its intended effect, and to respond to any concerns from its implementers, recipients or the community. Finally, major gaps in evidence are highlighted. These include: establishing levels of recognition of asphyxiated babies and effectiveness of local solutions for resuscitation; clarifying the extent of the overlap between community perceptions of ‘at risk’ babies and low birthweight babies; developing and evaluating effective interventions to enable ANC services to deliver effective behaviour change counselling for pregnant and newborn health; evaluating effectiveness of delivering community-based newborn interventions at scale through routine services.

Title: Newborn umbilical cord and skin care in Sylhet District Bangladesh: Implications for the promotion of umbilical cord cleansing with topical chlorhexidine.

Authors: Alam MA, Ali NA, Sultana S, Mullany LC, Teela KC, Khan NUZ, Baqui AH, EL Arifeen S, Mannan I, Darmstadt GL, Winch PJ.

Citation: J Perinatol. 2008;28(2):S61–S68. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2929163/

Abstract: Background: Newborn cord care practices may directly contribute to infections, which account for a large proportion of the 4 million annual global neonatal deaths. This formative research study assessed current umbilical and skin care knowledge and practices for neonates in Sylhet, Bangladesh in preparation for a cluster-randomised trial of the impact of topical chlorhexidine cord cleansing on neonatal mortality and omphalitis. Methodology-Unstructured interviews (n=60), structured observations (n=20), rating and ranking exercises (n=40), and household surveys (n=400) were conducted to elicit specific behaviours regarding newborn cord and skin care practices. These included hand-washing, skin and cord care at the time of birth, persons




engaged in cord care, cord cutting practices, topical applications to the cord at the time of birth, wrapping/dressing of the cord stump, and use of skin-to-skin care. Results: Ninety percent of deliveries occurred at home. The umbilical cord was almost always (98%) cut after delivery of the placenta, and cut by mothers in more than half the cases (57%). Substances were commonly (52%) applied to the stump after cord cutting; turmeric was the most common application (83%). Umbilical stump care revolved around bathing, skin massage with mustard oil, and heat massage on the umbilical stump. Forty-two percent of newborns were bathed on the day of birth. Mothers were the principal provider for skin and cord care during the neonatal period and 9% reported umbilical infections in their infants. Discussion: Unhygienic cord care practices are prevalent in the study area. Efforts to promote hand washing, cord cutting with clean instruments, and avoiding unclean home applications to the cord may reduce exposure and improve neonatal outcomes. Such efforts should broadly target a range of caregivers, including mothers and other female household members.

Title: Child health and mortality.

Author: Arifeen, SE.

Citation: J Health Popul Nutr. 2008;(3):273–279. http://www.ncbi.nlm.nih.gov/pubmed/18831224

Abstract: Bangladesh is currently one of the very few countries in the world, which is on target for achieving the Millennium Development Goal (MDG) 4 relating to child mortality. There have been very rapid reductions in mortality, especially in recent years and among children aged over one month. However, this rate of reduction may be difficult to sustain and may impede the achievement of MDG 4. Neonatal deaths now contribute substantially (57%) to overall mortality of children aged less than five years, and reductions in neonatal mortality are difficult to achieve and have been slow in Bangladesh. There are some interesting attributes of the mortality decline in Bangladesh. Mortality has declined faster among girls than among boys, but the poorest have not benefited from the reduction in mortality. There has also been a relative absence of a decline in mortality in urban areas. The age and cause of death pattern of under-five mortality indicate certain interventions that need to be scaled up rapidly and reach high coverage to achieve MDG 4 in Bangladesh. These include skilled attendance at delivery, postnatal care for the newborn, appropriate feeding of the young infant and child, and prevention and management of childhood infections. The latest (2007) Bangladesh Demographic and Health Survey shows that Bangladesh has made sustained and remarkable progress in many areas of child health. More than 80% of children are receiving all vaccines. The use of oral rehydration solution for diarrhoea is high, and the coverage of vitamin A among children aged 9–59 months has been consistently increasing. However, poor quality of care, misperceptions regarding the need for care, and other social barriers contribute to low levels of care-seeking for illnesses of the newborns and children. Improvements in the health system are essential for removing these barriers, as are effective strategies to reach families and communities with targeted messages and information. Finally, there are substantial health-system challenges relating to the design and implementation, at scale, of interventions to reduce neonatal mortality.

Title: Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomized controlled trial.

Authors: Baqui AH, El-Arifeen S, Darmstadt GL, Ahmed S, Williams EK, Seraji HR, Mannan I, Rahman SM, Shah R, Saha SK, Syed U, Winch PJ, Lefevre A, Santosham M, Black RE; the Projahnmo Study Group.





Abstract:

Background: Neonatal mortality accounts for a high proportion of deaths in children under the age of 5 years in Bangladesh. Therefore the project for advancing the health of newborns and mothers (Projahnmo) implemented a community-based intervention package through government and non-government organisation infrastructures to reduce neonatal mortality. Methods: In Sylhet district, 24 clusters (with a population of about 20 000 each) were randomly assigned in equal numbers to one of two intervention arms or to the comparison arm. Because of the study design, masking was not feasible. All married women of reproductive age (15–49 years) were eligible to participate. In the home-care arm, female community health workers (one per 4,000 population) identified pregnant women, made two antenatal home visits to promote birth and newborn-care preparedness, made postnatal home visits to assess newborns on the first, third, and seventh days of birth, and referred or treated sick neonates. In the community-care arm, birth and newborn-care preparedness and care seeking from qualified providers were promoted solely through group sessions held by female and male community mobilisers. The primary outcome was reduction in neonatal mortality. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, number 00198705. Findings: The number of clusters per arm was eight. The number of participants was 36059, 40159, and 37598 in the home-care, community-care, and comparison arms, respectively, with 14 769, 16 325, and 15 350 live births, respectively. In the last 6 months of the 30-month intervention, neonatal mortality rates were 29·2 per 1000, 45·2 per 1000, and 43·5 per 1000 in the home-care, community-care, and comparison arms, respectively. Neonatal mortality was reduced in the home-care arm by 34% (adjusted relative risk 0·66; 95% CI 0·47–0·93) during the last 6 months versus that in the comparison arm. No mortality reduction was noted in the community-care arm (0·95; 0·69–1·31). Interpretation: A home-care strategy to promote an integrated package of preventive and curative newborn care is effective in reducing neonatal mortality in communities with a weak health system, low health-care use, and high neonatal mortality. Funding: The United States Agency for International Development and Saving Newborn Lives Programme by Save the Children (US) with a grant from the Bill & Melinda Gates Foundation.

Title: Risk factors for umbilical cord infection among newborns of Southern Nepal.

Authors: Mullany LC, Darmstadt GL, Katz J, Khatry SK, LeClerq SC, Adhikari RK, Tielsch JM.

Citation: Am J Epidemiol. 2007;165(2):203–211. http://www.ncbi.nlm.nih.gov/pubmed/17065275

Abstract: Although umbilical cord infection contributes to neonatal mortality and morbidity and risk can be reduced with topical chlorhexidine, behavioral or other factors associated with cord infection in low-resource settings have not been examined. Data on potential risk factors for omphalitis were collected during a community-based, umbilical cord care trial in Nepal during 2002–2005. Newborns were evaluated in the home for signs of umbilical cord infection (pus, redness, and swelling). Omphalitis was defined as either pus discharge with erythema of the abdominal skin or severe redness (>2 cm extension from the cord stump) with or without pus. Multivariable regression modeling was used to examine associations between omphalitis and maternal, newborn, and household variables. Omphalitis was identified in 954 of 17,198 newborns (5.5%). Infection risk was 29% and 62% higher in infants receiving topical cord applications of mustard oil and other potentially unclean substances, respectively. Skin-to-skin contact (relative risk (RR) = 0.64, 95% confidence interval (CI): 0.43, 0.95) and hand washing by birth attendants (RR = 0.73, 95% CI: 0.64, 0.84) and caretakers (RR = 0.76, 95% CI: 0.60, 0.95) were associated with fewer infections. In this community, unhygienic newborn-care practices lead to continued high risk for omphalitis. In addition to topical antiseptics, simple, low-cost interventions such as hand





washing, skin-to-skin contact, and avoiding unclean cord applications should be promoted by community-based health workers.

Title: Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: A community-based, cluster-randomized trial.

Authors: Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM.

Citation: Lancet. 2006;367(9514):910–918. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2367116/

Abstract: Background: Omphalitis contributes to neonatal morbidity and mortality in developing countries. Umbilical cord cleansing with antiseptics might reduce infection and mortality risk, but has not been rigorously investigated. Methods: In our community-based, cluster-randomised trial, 413 communities in Sarlahi, Nepal, were randomly assigned to one of three cord-care regimens. 4934 infants were assigned to 4·0% chlorhexidine, 5107 to cleansing with soap and water, and 5082 to dry cord care. In intervention clusters, the newborn cord was cleansed in the home on days 1−4, 6, 8, and 10. In all clusters, the cord was examined for signs of infection (pus, redness, or swelling) on these visits and in follow-up visits on days 12, 14, 21, and 28. Incidence of omphalitis was defined under three sign-based algorithms, with increasing severity. Infant vital status was recorded for 28 completed days. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. Analysis was by intention-to-treat. This trial is registered with Clinicaltrials.gov, number NCT00109616. Findings: Frequency of omphalitis by all three definitions was reduced significantly in the chlorhexidine group. Severe omphalitis in chlorhexidine clusters was reduced by 75% (incidence rate ratio 0·25, 95% CI 0·12−0·53; 13 infections/4839 neonatal periods) compared with dry cord-care clusters (52/4930). Neonatal mortality was 24% lower in the chlorhexidine group (relative risk 0·76 [95% CI 0·55−1·04]) than in the dry cord care group. In infants enrolled within the first 24 h, mortality was significantly reduced by 34% in the chlorhexidine group (0·66 [0·46−0·95]). Soap and water did not reduce infection or mortality risk. Interpretation: Recommendations for dry cord care should be reconsidered on the basis of these findings that early antisepsis with chlorhexidine of the umbilical cord reduces local cord infections and overall neonatal mortality.

Title: Impact of umbilical cord cleansing with 4.0% chlorhexidine on time to cord separation among newborns in Southern Nepal: A cluster-randomized community-based trial.

Authors: Mullany LC, Darmstadt GL, Khatry SK, LeClerq SC, Katz J, Tielsch JM.

Citation: Pediatrics. 2006;118(5):1864–1871. http://www.ncbi.nlm.nih.gov/pubmed/17079556

Abstract: Objective: Within a community-based, cluster-randomized study of the effects of 4.0% chlorhexidine on omphalitis and mortality risk, we aimed to describe the distribution of times to separation and the impact of topical chlorhexidine treatment on cord-separation times. Methods: Between November 2002 and March 2005, 15123 infants were assigned randomly within communities in southern Nepal to receive 1 of the following 3 cord-care regimens: cleansing with 4.0% chlorhexidine, cleansing with soap and water, or dry cord care. In intervention clusters, field workers cleansed the cord in the home on days 1, 2, 3, 4, 6, 8, and 10 after birth. Newborns were monitored throughout the newborn period for signs of omphalitis, and the time to cord separation was noted. Separation times were compared across treatment groups. Cord infection risk and a range of infant and household characteristics were assessed for their relationships to separation time. Results: The mean separation time was shorter in dry cord care (4.24 days) and soap/water (4.25 days) clusters than in chlorhexidine clusters (5.32 days;





mean difference: 1.08 days). Cords of infants who received chlorhexidine were 3.6 times more likely to separate after 7 days. Separation time was not associated with omphalitis. Home-delivered topical antiseptics, facility-based birth, and birth attendant hand-washing were associated with greater likelihoods of cord separation after 7 days of age. Conclusions: In this setting, the umbilical cord separated more rapidly than observed in hospital-based studies, and the impact of chlorhexidine cleansing on separation times was negligible. Increased cord-separation time attributable to topical chlorhexidine treatment should not be considered a factor in decision-making in settings where the baseline risk of omphalitis is high and chlorhexidine might reduce infection and mortality risks significantly.

Title: Safety and impact of chlorhexidine antisepsis interventions for improving neonatal health in developing countries.

Authors: Mullany LC, Darmstadt GL, Tielsch JM.

Citation: Pediatr Infect Dis J. 2006;25(8):665–675. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2386993/

Abstract: Affordable, efficacious, and safe interventions to prevent infections and improve neonatal survival in low-resource settings are needed. Chlorhexidine is a broad-spectrum antiseptic that has been used extensively for many decades in hospital and other clinical settings. It has also been given as maternal vaginal lavage, full-body newborn skin cleansing, and/or umbilical cord cleansing to prevent infection in neonates. Recent evidence suggests that these chlorhexidine interventions may have significant public health impact on the burden of neonatal infection and mortality in developing countries. This review examines the available data from randomized and nonrandomized studies of chlorhexidine cleansing, with a primary focus on potential uses in low-resource settings. Safety issues related to chlorhexidine use in newborns are reviewed, and future research priorities for chlorhexidine interventions for neonatal health in developing countries are discussed. We conclude that maternal vaginal cleansing combined with newborn skin cleansing could reduce neonatal infections and mortality in hospitals of sub-Saharan Africa, but the individual impact of these interventions must be determined, particularly in community settings. There is evidence for a protective benefit of newborn skin and umbilical cord cleansing with chlorhexidine in the community in south Asia. Effectiveness trials in that region are required to address the feasibility of community-based delivery methods such as incorporating these interventions into clean birth kits or training programs for minimally skilled delivery assistants or family members. Efficacy trials for all chlorhexidine interventions are needed in low-resource settings in Africa, and the benefit of maternal vaginal cleansing beyond that provided by newborn skin cleansing needs to be determined.

Title: Role of antimicrobial applications to the umbilical cord in neonates to prevent bacterial colonization and infection: A review of the evidence.

Authors: Mullany LC, Darmstadt GL, Tielsch JM.


Abstract: In developing countries umbilical cord infections constitute a major cause of neonatal morbidity and pose significant risk for mortality, whereas outbreaks of cord infections continue to occur in developed country nurseries. Cord infections in developing countries can be prevented through increasing access to tetanus toxoid immunization during pregnancy, promoting clean cord care and reducing harmful cord applications and behaviors. Interventions introduced in both developed and developing countries to reduce exposure of the cord to infectious pathogens





include clean cord cutting, hand-washing before and after handling the baby, bathing of the infant with antimicrobial agents and application of antimicrobials to the cord. Despite the importance of umbilical cord care, both traditionally and medically, there have been few randomized trials investigating the impact of different cord care regimens on rates of local or systemic infections, particularly in developing countries. This review examines available data on umbilical cord care, with a particular focus on those comparing rates of bacterial colonization and/or rates of cord infection among neonates receiving different umbilical cord care regimens. Although most investigators agree that topical antimicrobials reduce bacterial colonization of the cord, a firm relationship between colonization and infection has not been established. Further research in developed countries, including follow-up beyond hospital discharge, is required before advising on “best cord care practices.” The paucity of published reports from developing countries indicates the need to investigate the impact of antimicrobial applications on cord and systemic infections in a community-based, prospective manner.

Title: Chlorhexidine cleansing of the umbilical cord in Nepal: leading by example and saving lives [Editorial]

Author: Mullany LC Citation: Journal of Institute of Medicine [Nepal]. 2013;36(2):1–2. http://www.jiom.com.np/ Title: Application of chlorhexidine to the umbilical cord after birth in low-income settings: two

randomised controlled trials. Author: Osrin D. Citation: Arch Dis Child Educ Pract Ed. 2012;97(6):236–237.

http://www.ncbi.nlm.nih.gov/pubmed/22904564 Title: Chlorhexidine cord cleansing to reduce neonatal mortality. Authors: Osrin D, Hill ZE. Citation: Lancet. 2012;379(9820):984–986. http://www.ncbi.nlm.nih.gov/pubmed/22322125 Title: Safety of chlorhexidine gluconate used for skin antisepsis in the preterm infant. Authors: Chapman AK, Aucott SW, Milstone AM. Citation: J Perinatol. 2011;32(1)4–9. http://www.ncbi.nlm.nih.gov/pubmed/22031047 Title: Randomized study of vaginal and neonatal cleansing with 1% chlorhexidine. Authors: Pereira L, Chipato T, Mashu A, Mushangwe V, Rusakaniko S, Bangdiwala S, Chidede OS,

Darmstadt GL, Gwanzura L, Kandawasvika G, Madzime S, Lumbiganon P, Tolosa JE. Citation: Int J Gynaecol Obstet. 2011;112(3)234–238. http://www.ncbi.nlm.nih.gov/pubmed/21247573 Title: Community-based health workers achieve high coverage in neonatal intervention trials: a case

study from Sylhet, Bangladesh. Authors: Shah R, Munos MK, Winch PJ, Mullany LC, Mannan I, Rahman SM, Rahman R, Hossain D, El

Arifeen S, Baqui AH. Citation: J Health Popul Nutr. 2010;28(6):610–618. http://www.ncbi.nlm.nih.gov/pubmed/21261207

Additional literature (most recent chronological order)


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Title: Elimination kinetics of chlorhexidine in milk following intramammary infusion to stop lactation in mastitic mammary gland quarters of cows.

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Title: Effect of cleansing the birth canal with antiseptic solution on maternal and newborn morbidity and mortality in Malawi: clinical trial.

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containing chlorhexidine gluconate. Authors: Gongwer LE, Hubben RS, Lenkiewicz RS, Hart ER, Cockrell BY. Citation: Toxicol Appl Pharmacol.1980:52(2):255–261. http://www.ncbi.nlm.nih.gov/pubmed/6767299 Title: Absorption of chlorhexidine from the intact skin of newborn infants. Authors: Cowen J, Ellis SH, McAinsh J. Citation: Arch Dis Child. 1979;54(5):379–383. http://www.ncbi.nlm.nih.gov/pubmed/475414 Title: Chlorhexidine, a hexachlorophene substitute in the nursery. Author: Maloney MH. Citation: Nurs Times. 1975;71(37):21. http://www.ncbi.nlm.nih.gov/pubmed/1161513 Title: Hibiscrub in the control of staphylococcal infection in neonates. Author: Tuke W. Citation: Nurs Times. 1975;71(37):20. http://www.ncbi.nlm.nih.gov/pubmed/1161512 Title: Letter: Staphylococcal infection in the newborn. Authors: Scopes JW, Eykyn S, Phillips I. Citation: Lancet. 1974;2(7893):1392. http://www.ncbi.nlm.nih.gov/pubmed/4143356

For more information, please visit the chlorhexidine technical resource page: http://www.healthynewbornnetwork.org/topic/chlorhexidine-umbilical-cord-care




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Chlorhexidine for Umbilical Cord Care: Selected Bibliography · Background: There is an increased...

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