EFFECT OF DOMPERIDONE ON THE

COMPOSITION OF PRETERM
HUMAN 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

Introduction

Breast milk is
generally
considered to be
the optimal form
of nutrition for all
infants

Mothers of very
preterm infants
often find it
difficult to provide
adequate
quantities of
expressed breast
milk to meet their
infants needs over
prolonged periods
of time

Medications such
as domperidone
and
metoclopramide
are often
recommended

Introduction

Domperidone

A gastric
motility agent

Used as a
galactagogue

Introduction
Breastfeeding
women not to
use
domperidone

Increased risk of cardiac arrhythmia and

sudden death observed in patients with cancer
with low serum potassium who were receiving
high-dose intravenous domperidone therapy
concurrently with chemotherapy

Introduction

Domperidone
antidopaminergic
increases
prolactin
concentration

augments
lactation.

10 mg or 20 mg
3 times daily

prokinetic
oral dose of
domperidone is
20 mg given 4
times/ day, and
transient

adverse effects
reported include
abdominal
cramps, dry
mouth, and
headache

Introduction

Galactagogues
Metoclopramide
Have been linked to accelerated declines in the
protein concentration of breast milk and also to
changes in the electrolyte composition of breast milk.

Patients And Methods

Conducted in a
tertiary level NICU
at the IWK Health
Centre in Halifax,
Nova Scotia,
Canada.

Study
Setting
and
Population
mothers who had delivered
infants at 31 weeks gestation,
who were mechanically
expressing breast milk by
using a double collecting
system, and who experienced
lactation failure 3 weeks after
delivery

Between October
2003 and November
2007

Include criteria
a decreasing milk
supply by 30% from
peak volume (based
on maternal
account)

inability to provide
adequate breast
milk to meet the
daily nutritional
intake of their infant
Lactation
failure was
defined by at
least 1 of the
following
criteria:

Exclude criteria

Considered ineligible
were taking
medication
known to alter
the effect of
domperidone
(eg, ranitidine)
or interact with
it (eg,
haloperidol)

Experiencing
mastitis

Chronic illness

Had previous
breast surgery,

Had known
lactose
intolerance

Already taking
domperidone

Study Outcomes

The primary outcome was the

within subject change in breast
milk protein concentration.

Secondary outcome included

within-subject changes in fat,
carbohydrate, lactose, energy,
calcium, phosphate, and
sodium content of breast milk.

Study Design and

Intervention
Eligible and consenting
women were randomly
assigned by using a
Computer-based code
in blocks of 4, known
only to off-site
pharmacy staff, to
receive domperidone
(10 mg orally, 3 times
daily) or placebo for a 2week period

Mothers of infants > 3

but < 4 weeks after
delivery were stratified
and randomly assigned
separately from those
mothers of infants >4
weeks after delivery

Study disign and intervention

Baseline measurements were

taken and recorded after
randomization (day 0).

Breast milk samples (30 mL

volume) were frozen (70C)
and couriered in batches of 8
for chemical analysis of
macronutrient content.

Sample size

Sample Size

Sample size
was calculated
by using a 2sided error
of .05 and a
power of 80%.

Statistical Analysis

Categorical data were analyzed by

using x2 tests.

Primary and secondary outcomes

were analyzed by comparing the
means of the within-subject
change before and after treatment
between the domperidone and
placebo groups

RESULTS

Results

Increase in
placebo
groups
protein

fat

In two groups
not signifikan

Increase in
domperidone

Carbphydrate

Sodium dan
fosfat

In two groups
not signifikan

Results

Results
Our study showed that
domperidone increased
serum prolactin levels and
breast milk volume
substantially,

these findings were

consistent with the known
effect of domperidone as a
galactagogue.

Conclusion
Our study shows that domperidone, at a dose of 10
mg 3 times daily for 2 weeks, effectively increases
breast milk volume without alteration in the
nutrient composition of very preterm mothers milk.
The increase in calcium concentration in breast milk
after domperidone use requires additional study
because it relates to both maternal and infant
effects.

pico
P Population

I Intervention
C Comparator
O Outcome

: forty-six mothers who had delivered infants at

< 31 weeks gestation and experienced
lactation failure
: domperidone
: plasebo
: Domperidone increase the volume of breast
milk without substantially altering the nutrient
composition

21

KAJIAN KRITIS KEDOKTERAN BERBASIS BUKTI

PROGNOSTIK
Are the results of this trial valid?

1. Was the assigment of patients to treatment

randomised and was the randomisation list
concealed ?
2. Were they analysed in the groups to which they
were randomised ?
3. Were patients and clinicians kept blind to which
teratment was being received?
4. Aside from the experimental treatment, were the
groups treated equally ?
5. Were the groups similiar at the start of the trial
?

Yes

Yes

Yes
Yes
Yes

22

Are the result of the trial importance?

1. How likely are the
outcomes over time ?

Analyzes using p value on day 0, 4,

7, and 14.
Significant
different
between
domperidone
and
placebo
groups on day 4, 7, 14.

2. How precise are the Significantly different between

estimate ?
domperidone and placebo group

23

Can we apply this to our patient ?

1. Were our patients similiar to those in the trial

?
2. Are they met by this regimen and its
consequences?

Yes

Yes

Conclusion :
Valid, important, applicable
24