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Lactose-free Infant Formula Does Not Change Outcomes of Neonatal Abstinence Syndrome (NAS): a Randomized Clinical Trial

Overview
Journal J Perinatol
Date 2020 Sep 2
PMID 32868858
Citations 6
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Abstract

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.

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References
1.
Patrick S, Schumacher R, Benneyworth B, Krans E, McAllister J, Davis M . Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012; 307(18):1934-40. DOI: 10.1001/jama.2012.3951. View

2.
Pansino F, Meara Jr J, Peppler J . Recurrent keratocysts in basal cell nevi syndrome. J Mich State Dent Assoc. 1974; 56(1):13-5. View

3.
Ko J, Patrick S, Tong V, Patel R, Lind J, Barfield W . Incidence of Neonatal Abstinence Syndrome - 28 States, 1999-2013. MMWR Morb Mortal Wkly Rep. 2016; 65(31):799-802. DOI: 10.15585/mmwr.mm6531a2. View

4.
Tolia V, Patrick S, Bennett M, Murthy K, Sousa J, Smith P . Increasing incidence of the neonatal abstinence syndrome in U.S. neonatal ICUs. N Engl J Med. 2015; 372(22):2118-26. DOI: 10.1056/NEJMsa1500439. View

5.
Nygaard E, Moe V, Slinning K, Walhovd K . Longitudinal cognitive development of children born to mothers with opioid and polysubstance use. Pediatr Res. 2015; 78(3):330-5. PMC: 4539602. DOI: 10.1038/pr.2015.95. View