Trial reportHospital pediatrics2018
Randomized Clinical Trial of Standard- Versus High-Calorie Formula for Methadone-Exposed Infants: A Feasibility Study.
Trial report in Hospital pediatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Eligible Infants Included in Neonatal Clinical Trials and Reasons for Noninclusion: A Systematic Review.JAMA network open · 2024Pooled it
- Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials: A Systematic Review.JAMA network open · 2023Pooled it
- Non-pharmacological care for opioid withdrawal in newborns.The Cochrane database of systematic reviews · 2020Pooled it
- Lactose-free infant formula does not change outcomes of neonatal abstinence syndrome (NAS): a randomized clinical trial.Journal of perinatology : official journal of the California Perinatal Association · 2021Trial
- Stochastic vibration and early weight growth in opioid-exposed newborns: a randomized trial.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Advances in the Care of Infants With Prenatal Opioid Exposure and Neonatal Opioid Withdrawal Syndrome.Pediatrics · 2024Review
- High-calorie, whole protein/peptide nutritional formulations for children with cerebral palsy: a retrospective clinical study.American journal of translational research · 2024Article
- Inpatient Growth in Infants Requiring Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome.International journal of pediatrics · 2024Article
- Growth failure in infants with neonatal abstinence syndrome in the neonatal intensive care unit.Journal of perinatology : official journal of the California Perinatal Association · 2022Article
- The immediate and long-term effects of prenatal opioid exposure.Frontiers in pediatrics · 2022Review
- Racial differences in opioid withdrawal syndrome among neonates with intrauterine opioid exposure.Pediatric research · 2021Observational
- Effect of Low Lactose Formula on the Short-Term Outcomes of Neonatal Abstinence Syndrome: A Systematic Review.Global pediatric health · 2021Review
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundNewborns who are prenatally exposed to methadone are at risk for neonatal abstinence syndrome and the associated excess weight loss and poor weight gain. This pilot feasibility study aimed to evaluate early caloric enhancement on weight patterns among infants born to women receiving methadone maintenance therapy while pregnant.
methodsIn this double-blind pilot feasibility study, we randomly assigned infants with fetal methadone exposure to 24 or 20 kcal/oz formula from days 3 to 21. Randomization was stratified by any breastfeeding, sex of the infant, and gestational age. Eligible infants were ≥35 weeks' gestation and weighed ≥2200 g. Outcomes were days to weight nadir, maximum percent weight loss, days to birth weight, percentage weight change per day, and feasibility.
resultsA total of 49 infants were randomly assigned (22 to standard- and 27 to high-calorie formula); groups had comparable demographic characteristics. Main outcomes comparing standard- to high-calorie formula groups were not significant (days to weight nadir, 5.0 vs 4.4 days;
conclusionsStudy findings suggest that early initiation of high-calorie formula for infants with prenatal methadone exposure may be beneficial for weight gain; evaluation in a larger study is warranted.
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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.