Evidence map›Paper›PMID 18507654›Full record

Trial reportBritish journal of clinical pharmacology2008

Dose-effect study of domperidone as a galactagogue in preterm mothers with insufficient milk supply, and its transfer into milk.

Elise W-X Wan, Kaye Davey, Madhu Page-Sharp, Peter E Hartmann, Karen Simmer, Kenneth F Ilett

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03221855 (Randomized Clinical Trial), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03221855 early_phase1completednot on this mapstarted 2013, after this paper: background citation

Randomized Clinical Trial: Use of Domperidone to Increase Milk Production in Mothers With Newborns Hospitalized in Neonatology

TypeinterventionalSponsorHospital de Clinicas de Porto AlegreRan2013 to 2016Enrolled30ConditionsBreastfeedingArmsDomperidone, Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 97 citations in OpenAlex.

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  20. Nipple Pain in Breastfeeding Mothers: Incidence, Causes and Treatments.International journal of environmental research and public health · 2015
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Elise W-X WanPharmacology and Anaesthesiology Unit, School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia.
Kaye Davey
Madhu Page-Sharp
Peter E Hartmann
Karen Simmer
Kenneth F Ilett
University of Western Australia · AUPathwest Laboratory Medicine · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate the possibility of a dose-response relationship for the use of domperidone in treating insufficient milk supply in mothers of preterm infants, and to quantify the exposure of the breastfed infant to domperidone.

methodsSix preterm mothers received domperidone (30 mg daily or 60 mg daily) in a double-blind, randomized, crossover trial. Milk production and serum prolactin were measured before and during the trial, and domperidone concentration in milk was measured during drug treatment.

resultsFor milk production, two of the mothers were 'nonresponders', whereas the other four were 'responders' and showed a significant increase in milk production from 8.7 +/- 3.1 g h(-1) in the run-in phase (mean +/- SEM), 23.6 +/- 3.9 g h(-1) for the 30-mg dose (P = 0.0217) and 29.4 +/- 6.6 g h(-1) for the 60-mg dose (P = 0.0047). In all participants, serum prolactin was significantly increased for both doses, but the response was not dose dependent. Median (interquartile range) domperidone concentrations in milk over a dose interval at steady-state were 0.28 microg l(-1) (0.24-0.43) and 0.49 microg l(-1) (0.33-0.72) for the 30-mg and 60-mg doses, respectively. The mean relative infant dose was 0.012% at 30 mg daily and 0.009% at 60 mg daily.

conclusionIn one-third of mothers, domperidone did not increase milk production. In the remainder, milk production increased at both domperidone doses, and there was a trend for a dose-response relationship. The amount of domperidone that transfers into milk was extremely low, and infant exposure via breastfeeding was not considered to be significant.

Indexed as

Obstetric Labor, PrematureBreast FeedingClinical ProtocolsDomperidoneDopamine AntagonistsDose-Response Relationship, DrugFemaleHumansInfant, NewbornLactationLactation DisordersMilk, HumanPregnancyTreatment OutcomeDomperidoneDopamine Antagonists

Identifiers

PMID18507654
PMCPMC2492930
OpenAlexW2029263847

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.