Enhancing Breast Milk Production with Domperidone in Mothers of Preterm Neonates: A Randomized Controlled Trial (Empower Trial)
Bibliographic record
Abstract
Abstract BACKGROUND: Using mother’s own expressed breast milk (EBM) has a positive impact in reducing serious neonatal morbidities and improving neurodevelopmental outcomes for very preterm infants. Mothers often struggle to maintain a supply of EBM during prolonged hospitalization. In small studies, domperidone, a potent dopamine D2 receptor antagonist that stimulates the release of prolactin, has been shown to enhance EBM production. OBJECTIVES: The primary objective was to determine whether administration of domperidone, within the first 21 days after delivery, would lead to a higher proportion of mothers having a 50% increase in the volume of EBM at the end of 14 days of treatment. The secondary objectives were to determine if a 28 day compared to a 14 day treatment yielded a higher proportion of mothers with a 50% increase in EBM volumes; and 2) to determine if a later initiation of domperidone differed in obtaining a 50% increase in EBM volume. DESIGN/METHODS: EMPOWER was a multicenter, double masked, randomized controlled phase-II trial. Eligible mothers were randomized to one of two treatment arms: group A: domperidone 10 mg orally three times daily for 28 days; 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. RESULTS: A total of 90 mothers were randomized equally into the 2 arms; 82 were included in the analysis of the primary outcome. Baseline characteristics were similar between the two groups of mothers. There was a significant difference in the proportion of mothers who achieved a 50% increase in EBM volume at the end of the first 14 days of the study treatment: 77.8% in group A vs. 57.8% in group B [OR 0.39, 95% CI 0.16, 0.98, p=0.04] However, there was no difference in the proportion of mothers who achieved a 50% increase in EBM volume on day 28: 68.9% in group A vs. 66.7% in group B [OR .90, 95% CI 0.37, 2.19]. CONCLUSION: Introducing a galactogogue may be helpful in aiding mothers of preterm infants who present with an insufficient supply of EBM within the first 21 to 35 days after birth.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".