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EFFECT OF DOMPERIDONE ON THE
COMPOSITION OF PRETERMHUMAN BREAST MILK
Marsha L. Campbell-Yeo, MN Alexander C.Allen, MD, K. S. Joseph, MD, PhD,Joyce M. Ledwidge,PDt,a Kim Caddell, BscN,a Victoria M. Allen, MD, MSc,
and Kent C. Dooley, PhD
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Introduction
Breast milk isgenerally
considered to bethe optimal formof nutrition for all
infants
Mothers of verypreterm infants
often find itdifficult to provide
adequatequantities of
expressed breastmilk to meet their
infants needs overprolonged periods
of time
Medications suchas domperidone
andmetoclopramide
are often
recommended
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Introduction
DomperidoneA gastric
motility agentUsed as a
galactagogue
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Introduction
Increased risk of cardiac arrhythmia andsudden death observed in patients with cancerwith low serum potassium who were receivinghigh-dose intravenous domperidone therapy
concurrently with chemotherapy
Breastfeedingwomen not to
usedomperidone
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Introduction
Domperidone
antidopaminergic
increasesprolactin
concentration
augmentslactation.
10 mg or 20 mg3 times daily
prokinetic
oral dose ofdomperidone is20 mg given 4
times/ day, andtransient
adverse effectsreported include
abdominalcramps, drymouth, andheadache
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Introduction
Galactagogues
Metoclopramide
Have been linked to accelerated declines in theprotein concentration of breast milk and also tochanges in the electrolyte composition of breast milk.
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Patients And Methods
StudySetting
andPopulation
Conducted in atertiary level NICUat the IWK HealthCentre in Halifax,
Nova Scotia,Canada.
Between October2003 and November
2007
mothers who had deliveredinfants at 31 weeks gestation,
who were mechanicallyexpressing breast milk byusing a double collecting
system, and who experiencedlactation failure 3 weeks after
delivery
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Exclude criteria
Considered ineligible
were takingmedication
known to alterthe effect of
domperidone(eg, ranitidine)or interact with
it (eg,haloperidol)
Experiencing
mastitis Chronic illness
Had previous
breast surgery,
Had known
lactoseintolerance
Already taking
domperidone
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Study Outcomes
The primary outcome was thewithin subject change in breast
milk protein concentration.
Secondary outcome includedwithin-subject changes in fat,
carbohydrate, lactose, energy,calcium, phosphate, and
sodium content of breast milk.
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Study Design and
InterventionEligible and consentingwomen were randomly
assigned by using aComputer-based codein blocks of 4, known
only to off-sitepharmacy staff, to
receive domperidone(10 mg orally, 3 times
daily) or placebo for a 2-week period
Mothers of infants > 3but < 4 weeks afterdelivery were stratifiedand randomly assignedseparately from those
mothers of infants >4weeks after delivery
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Study disign and intervention
Baseline measurements weretaken and recorded after
randomization (day 0).
Breast milk samples (30 mLvolume) were frozen (70C)and couriered in batches of 8for chemical analysis ofmacronutrient content.
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Sample size
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Sample Size
Sample sizewas calculatedby using a 2-sided error
of .05 and apower of 80%.
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Statistical Analysis
Categorical data were analyzed byusing x2 tests.
Primary and secondary outcomeswere analyzed by comparing themeans of the within-subject
change before and after treatmentbetween the domperidone and
placebo groups
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RESULTS
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Results
Increase inplacebogroups
protein
In two groupsnot signifikan
fat Increase in
domperidone
Carbphydrate
In two groupsnot signifikan
Sodium danfosfat
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Results
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Results
Our study showed thatdomperidone increased
serum prolactin levels andbreast milk volume
substantially,
these findings wereconsistent with the knowneffect of domperidone as a
galactagogue.
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Conclusion
Our study shows that domperidone, at a dose of 10mg 3 times daily for 2 weeks, effectively increases
breast milk volume without alteration in thenutrient composition of very preterm mothers milk.
The increase in calcium concentration in breast milk
after domperidone use requires additional studybecause it relates to both maternal and infanteffects.
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pico
P Population : forty-six mothers who had delivered infants at< 31 weeks gestation and experiencedlactation failure
I Intervention : domperidoneC Comparator : plasebo
O Outcome : Domperidone increase the volume of breastmilk without substantially altering the nutrient
composition
21
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1. Was the assigment of patients to treatmentrandomised and was the randomisation listconcealed ?
Yes
2. Were they analysed in the groups to which theywere randomised ?
Yes
3. Were patients and clinicians kept blind to whichteratment was being received?
Yes
4. Aside from the experimental treatment, were thegroups treated equally ?
Yes
5. Were the groups similiar at the start of the trial?
Yes
KAJIAN KRITIS KEDOKTERAN BERBASIS BUKTI
PROGNOSTIK
Are the results of this trial valid?
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1. How likely are theoutcomes over time ?
Analyzes using p value on day 0, 4,
7, and 14.Significant different between
domperidone and placebogroups on day 4, 7, 14.
2. How precise are the
estimate ?Significantly different betweendomperidone and placebo group
Are the result of the trial importance?
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Can we apply this to our patient ?
1. Were our patients similiar to those in the trial?
Yes
2. Are they met by this regimen and itsconsequences?
Yes
Conclusion :
Valid, important, applicable
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