Trial reportPediatrics2013
Effect of early limited formula on duration and exclusivity of breastfeeding in at-risk infants: an RCT.
Trial report in Pediatrics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02221167 (Rx Milk), which is not on this map. Cited by 34 papers, 4 of them syntheses 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.
Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
Who cites it
34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 89 citations in OpenAlex.
- Why do mothers mix milk feed their infants? Results from a systematic review.Nutrition reviews · 2024Pooled it
- Impact of prelacteal feeds and neonatal introduction of breast milk substitutes on breastfeeding outcomes: A systematic review and meta-analysis.Maternal & child nutrition · 2022Pooled it
- Feeding Interventions for Infants with Growth Failure in the First Six Months of Life: A Systematic Review.Nutrients · 2020Pooled it
- Early additional food and fluids for healthy breastfed full-term infants.The Cochrane database of systematic reviews · 2016Pooled it
- Effect of Early Limited Formula on Breastfeeding Duration in the First Year of Life: A Randomized Clinical Trial.JAMA pediatrics · 2019Trial
- Effect of Donor Milk Supplementation on Breastfeeding Outcomes in Term Newborns: A Randomized Controlled Trial.Clinical pediatrics · 2019Trial
- Determinants of breastfeeding discontinuation in an Italian cohort of mother-infant dyads in the first six months of life: a randomized controlled trial.Italian journal of pediatrics · 2018Trial
- Relationship of newborn weight loss to milk supply concern and anxiety: the impact on breastfeeding duration.Maternal & child nutrition · 2016Trial
- BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial.Trials · 2016Trial
- Trial
- Randomized pilot study comparing standard vs high-calorie feeding in infants with Neonatal Opioid Withdrawal Syndrome.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Breastfeeding duration and maternal weight change through adulthood in a population-based cohort study.The American journal of clinical nutrition · 2026Article
- Development and validation of a prediction model for rebound hyperbilirubinemia: a Chinese neonatal cohort study.Translational pediatrics · 2024Article
- Do various types of prelacteal feeding (PLF) have different associations with breastfeeding duration in Indonesia? A cross-sectional study using Indonesia Demographic and Health Survey datasets.BMJ global health · 2024Article
- Perspective: Supporting Maternal Efforts to Provide Optimal Infant Nutrition in the Post-Partum Setting.Advances in nutrition (Bethesda, Md.) · 2024Article
- In-Hospital Formula Feeding Hindered Exclusive Breastfeeding: Breastfeeding Self-Efficacy as a Mediating Factor.Nutrients · 2023Article
- Self-Efficacy and Outcomes in Women with Diabetes: A Prospective Comparative Study.Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine · 2023Article
- Fatal Hypernatremic Dehydration in a Term Exclusively Breastfed Newborn.Children (Basel, Switzerland) · 2022Article
- Article
- Review
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Authors and funding
6 authors at 5 institutions in 1 country.
Funding
Abstract
BACKGROUND AND
objectivesRecent public health efforts focus on reducing formula use for breastfed infants during the birth hospitalization. No previous randomized trials report the effects of brief early formula use. The objective of the study was to determine if small formula volumes before the onset of mature milk production might reduce formula use at 1 week and improve breastfeeding at 3 months for newborns at risk for breastfeeding problems.
methodsWe randomly assigned 40 exclusively breastfeeding term infants, 24 to 48 hours old, who had lost ≥5% birth weight to early limited formula (ELF) intervention (10 mL formula by syringe after each breastfeeding and discontinued when mature milk production began) or control (continued exclusive breastfeeding). Our outcomes were breastfeeding and formula use at 1 week and 1, 2, and 3 months.
resultsAmong infants randomly assigned to ELF during the birth hospitalization, 2 (10%) of 20 used formula at 1 week of age, compared with 9 (47%) of 19 control infants assigned during the birth hospitalization to continue exclusive breastfeeding (P = .01). At 3 months, 15 (79%) of 19 infants assigned to ELF during the birth hospitalization were breastfeeding exclusively, compared with 8 (42%) of 19 controls (P = .02).
conclusionsEarly limited formula may reduce longer-term formula use at 1 week and increase breastfeeding at 3 months for some infants. ELF may be a successful temporary coping strategy for mothers to support breastfeeding newborns with early weight loss. ELF has the potential for increasing rates of longer-term breastfeeding without supplementation based on findings from this RCT.
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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.