Lactose-free Infant Formula Does Not Change Outcomes of Neonatal Abstinence Syndrome (NAS): a Randomized Clinical Trial
Overview
Authors
Affiliations
Objective: To determine if lactose-free formula, compared to lactose-containing formula, decreases the cumulative morphine dose required to treat neonatal abstinence syndrome (NAS).
Study Design: In 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.
Results: Data 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.
Conclusion: Lactose-free vs. lactose-containing infant formula did not change the outcomes of infants with NAS.
Shaikh H, Lyle A, Oslin E, Gray M, Weiss E JAMA Netw Open. 2024; 7(10):e2441372.
PMID: 39453652 PMC: 11581680. DOI: 10.1001/jamanetworkopen.2024.41372.
Mascarenhas M, Wachman E, Chandra I, Xue R, Sarathy L, Schiff D Pediatrics. 2024; 153(2).
PMID: 38178779 PMC: 10827648. DOI: 10.1542/peds.2023-062871.
Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials: A Systematic Review.
Lyle A, Shaikh H, Oslin E, Gray M, Weiss E JAMA Netw Open. 2023; 6(12):e2348882.
PMID: 38127349 PMC: 10739112. DOI: 10.1001/jamanetworkopen.2023.48882.
Moreira D, Gregory S, Younge N Nutr Clin Pract. 2023; 38 Suppl 2:S56-S65.
PMID: 37721458 PMC: 10662944. DOI: 10.1002/ncp.11038.
The immediate and long-term effects of prenatal opioid exposure.
Yen E, Davis J Front Pediatr. 2022; 10:1039055.
PMID: 36419918 PMC: 9676971. DOI: 10.3389/fped.2022.1039055.