Effect of Domperidone on the Composition of Preterm English

8/10/2019 Effect of Domperidone on the Composition of Preterm English

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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

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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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Documents

Effect of Domperidone on the Composition of Preterm English