Trial reportJournal of perinatology : official journal of the California Perinatal Association2021
Lactose-free infant formula does not change outcomes of neonatal abstinence syndrome (NAS): a randomized clinical trial.
Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 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
- Term infant formula macronutrient composition: An update for clinicians.Journal of pediatric gastroenterology and nutrition · 2025Review
- Evaluating Nutritional Selection and Outcomes in Neonatal Abstinence Syndrome: A Retrospective Review.American journal of perinatology · 2025Article
- Advances in the Care of Infants With Prenatal Opioid Exposure and Neonatal Opioid Withdrawal Syndrome.Pediatrics · 2024Review
- Human milk fortification and use of infant formulas to support growth in the neonatal intensive care unit.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2023Review
- The immediate and long-term effects of prenatal opioid exposure.Frontiers in pediatrics · 2022Review
- Effect of Low Lactose Formula on the Short-Term Outcomes of Neonatal Abstinence Syndrome: A Systematic Review.Global pediatric health · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine if lactose-free formula, compared to lactose-containing formula, decreases the cumulative morphine dose required to treat neonatal abstinence syndrome (NAS). STUDY
designIn a double-blind clinical trial, we randomized 74 infants (36-42 weeks gestation) at risk for developing NAS due to in-utero exposure to opioids to receive either lactose-free (Similac Sensitive®) or lactose-containing (Similac Advance®) infant formula. The primary outcome measure was the cumulative dose of morphine used for the treatment of NAS during the first 14 days of life.
resultsData on 69 (4 withdrew consent and 1 ineligible)/74 randomized infants were analyzed. Patient characteristics between the infant groups fed lactose-free (n = 34) vs. lactose-containing (n = 35) infant formula were similar except more common maternal heroin abuse in the latter group (p = 0.013). Cumulative morphine dose (20.7 ± 19.8 vs. 23 ± 23.5 mg, p = 0.61) between the two groups were similar.
conclusionLactose-free vs. lactose-containing infant formula did not change the outcomes of infants with NAS.
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.