Trial reportBMC pregnancy and childbirth2012
Enhancing breast milk production with Domperidone in mothers of preterm neonates (EMPOWER trial).
Trial report in BMC pregnancy and childbirth, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01512225 (Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled 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.
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.
Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Domperidone and Risk of Ventricular Arrhythmia and Cardiac Death: A Systematic Review and Meta-analysis.Clinical drug investigation · 2016Pooled it
- Role of days postdelivery on breast milk production: a secondary analysis from theInternational breastfeeding journal · 2019Trial
- Exploration of potential mechanisms and biomarkers related to ERS-associated RCD in steroid-induced osteonecrosis of the femoral head based on bioinformatics, with experimental validation.Frontiers in endocrinology · 2026Article
- Early Breast Milk Volumes and Response to Galactogogue Treatment.Children (Basel, Switzerland) · 2022Article
- Pregnancy gestation at delivery and breast milk production: a secondary analysis from theMaternal health, neonatology and perinatology · 2018Article
- Should Domperidone be Used as a Galactagogue? Possible Safety Implications for Mother and Child.Drug safety · 2017Article
- Maternal experiences with and sources of information on galactagogues to support lactation: a cross-sectional study.International journal of women's health · 2017Article
- A Review of Herbal and Pharmaceutical Galactagogues for Breast-Feeding.Ochsner journal · 2016Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe use of mother's own breast milk during initial hospitalization has a positive impact not only in reducing potential serious neonatal morbidities but also contribute to improvements in neurodevelopmental outcomes. Mothers of very preterm infants struggle to maintain a supply of breast milk during their infants' prolonged hospitalization. Galactogogues are medications that induce lactation by exerting its effects through oxytocin or prolactin enhancement. Domperidone is a potent dopamine D2 receptor antagonist which stimulates the release of prolactin. Small trials have established its ability in enhancing breast milk production. EMPOWER was designed to determine the safety and efficacy of domperidone in mothers experiencing an inadequate milk supply. METHODS/
designEMPOWER is a multicenter, double masked, randomized controlled phase-II trial to evaluate the safety and effectiveness of domperidone in those mothers identified as having difficulty in breast milk production. Eligible mothers will be randomized to one of two allocated groups: Group A: domperidone 10 mg orally three times daily for 28 days; and Group B: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days. The primary outcome will be determined at the completion of the first 2-week period; the second 2-week period will facilitate answering the secondary questions regarding timing and duration of treatment. To detect an estimated 30% change between the two groups (from 40% to 28%, corresponding to an odds ratio of 0.6), a total sample size of 488 mothers would be required at 80% power and alpha=0.05. To account for a 15% dropout, this number is increased to 560 (280 per group). The duration of the trial is expected to be 36-40 months. DISCUSSION: The use of a galactogogue often becomes the measure of choice for mothers in the presence of insufficient breast milk production, particularly when the other techniques are unsuccessful. EMPOWER is designed to provide valuable information in guiding the practices for this high-risk group of infants and mothers. The results of this trial will also inform both mothers and clinicians about the choices available to increase and maintain sufficient breast milk.
trial registrationClinical Trials.gov Identifier: NCT01512225.
Indexed as
Identifiers
What OpenQuestion holds
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.