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Lactose-free infant formula does not change outcomes of neonatal abstinence syndrome (NAS): a randomized clinical trial

Journal of Perinatology volume 41, pages 598–605 (2021)Cite this article

Subjects

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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Acknowledgements

The authors thank all the parents of participating infants, nursing, and medical staff in L&D, newborn nursery, and the NICU.

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Authors and Affiliations

  1. Department of Pediatrics, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA

    Rajesh Pandey, Neelakanta Kanike, Mugahid Ibrahim, Namita Swarup, Dennis M. Super, Sharon Groh-Wargo & Deepak Kumar

  2. Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA

    Rajesh Pandey

  3. Pediatrics, Deaconess Women’s Hospital, Newburgh, IN, USA

    Neelakanta Kanike

  4. Department of Pediatrics, Cork University Maternity Hospital (CUMH), Cork, Ireland

    Mugahid Ibrahim

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  1. Rajesh Pandey
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Contributions

RP, NK, MI researched, designed the study, recruited patients, contributed to data interpretation, read and edited the paper. NS recruited patients, read and edited the paper. DS designed the study, analyzed and interpreted the data, and edited the paper. SGW researched, designed the study, contributed to data interpretation, and edited the paper. DK researched, designed the study, contributed to data analysis and interpretation, wrote and edited the paper. RP, NK, MI, NS, DS, SGW, DK read, edited, and approved the final version of the paper. DK is the guarantor of this work and had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Corresponding author

Correspondence to Deepak Kumar.

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Pandey, R., Kanike, N., Ibrahim, M. et al. Lactose-free infant formula does not change outcomes of neonatal abstinence syndrome (NAS): a randomized clinical trial. J Perinatol 41, 598–605 (2021). https://doi.org/10.1038/s41372-020-00797-7

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