Critical Appraisl : Early Vs Late refeeding in Children with acute diarrhoea

Dr. Shubhra Prakash Paul MD (Ped.) Part II

Bangladesh Institute of Child Health

Title

Early versus Delayed

Refeeding for Children

with Acute Diarrhoea

(Intervention Review)

AuthorsGregorio GV, Dans

LF, Silvestre MA

Journal

Evidence-based Child

Health: a Cochrane Review

Journal

2012; 7:2: 721–757.

DOI 10.1002/ebch.1835

Article Particulars

Acute diarrhea is one of the principal

causes of morbidity and mortality among

children in developing countries.

Oral rehydration therapy and dietary

management is the cornerstone of

treatment.

There is a lack of data and studies on

both the timing and type of feeding that

should be adopted during the course of

the illness.

Background

To compare the efficacy and safety

of early and late reintroduction of

feeding in children with acute

diarrhea.

Objective

Methodology

Criteria for considering studies for

this review

I. Types of studies

Randomized Controlled Trial (RCT)

II. Types of participants

Children less than 10 years old with

acute diarrhea, including both

breastfed and non-breastfed

Methodology

III. Types of Intervention

Intervention: Early Refeeding group

Feeding was reintroduced within 12

hours from start of rehydration;

continuous breastfeeding during

rehydration was included in this group.

Control: Late Refeeding group

Feeding was reintroduced more than

12 hours after start of rehydration.

Methodology

IV. Types of Outcome Measure

Primary

Duration of diarrhea (hours) from

admission until cessation of diarrhoea.

Secondary

• Total stool output (ml/kg) during the

first 24 hours and 48 hours after start

of rehydration.

• Percentage weight gain 24 hours

after start of rehydration and at

resolution of diarrhea.

Methodology

III. Types of Outcome Measure contd.

Secondary contd.

• Unscheduled intravenous (IV) fluid

therapy.

• Cases of vomiting

Adverse events (all adverse effects including)

• Hyponatraemia (low sodium; serum

sodium level ≤130 mmol/L),

• Hypokalaemia (low potassium;

serum potassium level ≤3

mmol/L), and

• Development of persistent diarrhoea

Search Engine used

• Cochrane Infectious Diseases Group

Specialized Register (May 2011)

• CENTRAL (The Cochrane Library

2011, Issue1)

• MEDLINE (1966 to May 2011)

• EMBASE (1974 to May 2011)

• LILACS (1984 to May 1981) and

• mRCT (metaRegister of Controlled

Trial)

Methodology

Search Method

Methodology

Search Method

Search terms used

‘diarrhoea’, ‘refeeding’,

‘breastfeeding’ and ‘feeding’

Searched researcher and organizations• World Health Organization:

• Child Health and Nutrition Research

Initiative

• International Clinical Epidemiology

Network USAID;

• Asian Development Bank;

• World Bank

• International Centre for Diarrheal

Disease Research, Bangladesh

(ICDDR,B)

Methodology

Search Method

Data collection and analysis

Trial selection

Trials are selected by the first two

authors.

Assessment of risk of bias

Risk of bias of each trial is assessed

using six components: Sequence

generation, Allocation, Concealment,

Blinding, Incomplete outcome data,

Selective outcome reporting and other

biases.


Assessment of risk of bias (contd.)

Trials are classified into two groups high

risk of bias (trials with unclear sequence

generation or allocation or concealment

and trials where less than 90% of

randomized participants completed the

trial) and low risk of bias. Studies with

low risk of bias were included.


Data extraction and management

For continuous outcomes, authors extracted

arithmetic means and standard deviations for

each treatment group and noted the number

of participants in each group. In trials with

multiple interventions (where two or more

types of feeding were used as treatment

groups), authors pooled the means and

standard deviations of the different feeding

groups across the treatment arms


Data analysis

The authors

• Analysed the data using Review Manager

5 and all results were presented with a

95% confidence interval (CI).

• Combined trials that compared early

versus late feeding using meta-analysis.

• Analyzed data using an available case

approach (i.e. all patients for whom an

outcome was measured and reported are

included in the analysis).


Data analysis

• Compared dichotomous data using risk

ratio. The mean difference was used to

combine continuous data summarized by

arithmetic means and standard deviation.

Data collection and analysisSubgroup analysis and investigation of heterogeneity

• The presence of statistical heterogeneity

among the interventions was evaluated by

inspecting the forest plot and by performing a 2 test for heterogeneity using a p value of

0.10 to determine statistical significance.

• Subgroup analysis is used to investigate the

effect of age , nutritional status (normal and

mild malnutrition versus moderate and severe

malnutrition),


Subgroup analysis and investigation of heterogeneitybreastfeeding (breastfed and non-breastfed

infants) and type of food reintroduced (diluted

versus full-strength milk formula, lactose-free

versus lactose containing)

Result

Result of the search

22 relevant trials are assessed

• 12 trials are selected

• 10 trials are excluded

5 Trials do not satisfy the definition

of early or late refeeding used in this

review

3 Trials were unclear about when

the refeeding started

2 Trials were not randomized

controlled trials

Result

Total 1283 patients in 12 trials are included

(757 for early refeeding and 526 for late

refeeding)

Drop out

1226 patients were used in the final

analysis

Late refeeding

( 502 )

Early

refeeding

(724 )

Result

Location

12 Trials were conducted in 16 countries

• 1 Multicentre study including 11

European countries

• Each 2 trials from UK, USA, Burma and

Israel

• Each 1 trial from Egypt, Pakistan and

Peru

Among these 12

• 10 trials conducted in hospital setting

• 2 trials enrolled patients from out patient

clinic

Result

Participants All trials included children with acute diarrhea

of 14 days or less in duration.

• 6 trials ---- duration of diarrhoea 5 – 7 days

• 4 trials ---- duration of diarrhoea < 72 hours

Age All trials included children less than five years

old.Only two trials considered the nutritional status of the

participants.

• 6 trials ---- Age of children < 2 years of age

• 2 trials ---- Age of children 3 months to 3

years

Result

Type and timing of refeeding

Early feeding group• Half- or full-strength cow’s milk formula - 4

trials

• Boiled rice or the child’s usual diet –3 trials

• Soy-based milk formula - 2 trials

• Breast milk or cow’s milk formula - 1 trial

• Another trial allocated patients to receive

either oral rehydration solution and

breastfeeding during the rehydration phase or

oral rehydration alone for 24 hours

Result

Type and timing of refeeding

Late feeding group• Feeding after start of rehydration was

allowed either after 24 hours – 7 trials

• 48 hours – 2 trials

• 20 hours – 1 trial

• between 24 and 48 hours – 1 trial

• One trial allowed feeding only after the

diarrhea had stopped

Result

Duration of Follow up Trials

Until resolution of diarrhoea 6

Two weeks after hospital discharge 5

Once full strength milk formula could

be tolerated

1

Result

Outcome reported

Overall mean duration of diarrhea from

admission to resolution

7

The number who required unscheduled use of IV

fluids

6

Total stool output in the first 24 hours 3

Oral intake in the form of ORS, formula or rice

between 24 and 48 hours

6

Mean percentage weight gain at the 24th hour

after start of rehydration

3

Mean percentage weight gain at the resolution of

diarrhoea

3

Forest plot of early versus late

refeeding in the outcome of

unscheduled use of intravenous fluids

There was no significant difference in both groups in the

number of participants who needed IV fluids (RR 0.87, 95% CI

0.48 to - 1.59; 813 participants, 6 trials

Result

Outcome reported contd.

The number of participants with vomiting 4

The development of persistent diarrhea 4

The length of hospital stay 2

Monitored patients for development of

hyponatraemia or hypokalaemia

3

Result

Effects of intervention

I. Duration of diarrhea (hours) from

admission until cessation of

diarrhoea

• Shorter Duration

Early feeding group 2 trial

Late feeding group 1 trial

• Similar outcome on both group 4

trial

Result


II. Total stool output (ml/kg) during the

first 24 and 48 hours after start of

rehydration

After rehydration total stool output in

The first 24 hours 3 trials

48 hours 3 trials

Less stool output

24 hours (early refeeding) 1 trial

48 hours (Late refeeding) 1 trial

Result


III. Percentage weight gain at the 24th hour

after start of rehydration and at

resolution of diarrhea

No difference was observed in the mean

percentage weight gain at the 24th

hour after start of rehydration and at

resolution of illness

IV. Cases of vomiting

No significant difference between the

two groups in the number of patients

with episodes of vomiting (RR 1.16, 95% CI

0.72 to 1.86; 456 participants, five

trials)

Result


V. Adverse events: development of

persistent diarrhea

There was no significant difference in

the number of patients who developed

persistent diarrhea (RR 0.57, 95% CI

0.18 to 1.85; 522 participants, four trials)

Some physicians still recommend variable

periods of fasting during acute diarrhea to

allow ’bowel rest’ followed by gradual

reintroduction of food. The proponents of this

practice contend that early refeeding may

increase the stool output and lead to more

complications, such as unscheduled use of IV

fluids, episodes of vomiting, and persistent

diarrhea.

Present meta-analysis did not provide

evidence that early refeeding increases

unscheduled use of IV fluids, episodes of

vomiting, and development of persistent

diarrhea.

Discussion

The results support existing practice of early

refeeding during or after start of rehydration of

patients

The review clearly shows that early refeeding

does not adversely affect the secondary

outcome measures: stool output, weight gain

at the end of treatment (which ) likely reflects

rehydration, the unpredicted need for

intravenous fluids, onset of vomiting,

persistence of diarrhea, hyponatremia or

length of hospital stay.

Discussion

Limitation of the study

• 7 of the 12 trials (with 1283 participants)

included in this review came from high –

income countries limiting the applicability

for low-income countries.

• Quality assurance is difficult because 8

trials were published in or before 1990,

when the methods rarely included details

about randomization, allocation,

concealment or blinding

• Heterogeneity regarding participants,

interventions and outcome measures

Limitation of the study

• No data were provided on the aetiology of

acute diarrhoea, but different organisms

have varying influence on a child’s

symptoms, severity of dehydration,

tolerance of food and thus rate of

recovery

• No consideration was given to use of

adjuvant treatment such as zinc,

probiotics.

Recommendation

Further trials with more homogenous

populations (particularly children at high

risk from recurrent diarrhea and

malnutrition with diarrhea of known

etiology) is recommended

Message

There is little additional risk of

unscheduled use of IV fluids, persistent

diarrhea, vomiting or longer hospital stays

for children who were re-fed early. So

there is no need to keep the bowel at rest

during the episode of acute watery

diarrhea.

Critical Appraisl : Early Vs Late refeeding in Children with acute diarrhoea

Health & Medicine

Transcript of Critical Appraisl : Early Vs Late refeeding in Children with acute diarrhoea