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Am J Perinatol
DOI: 10.1055/a-2624-7278
Original Article

The Impact of Opt-In versus Opt-Out Consent Process for the Use of Donor Human Milk on Feeding Practice and Growth Pattern in Preterm Neonates

Authors

  • Christhian Cano-Guerra 

    1   Division of Newborn Medicine, Boston Children's, Boston, Massachusetts

  • Meghan I. Short

    2   Department of Biostatistics, Epidemiology, and Research Design, Tufts Clinical and Translational Science Institute, Boston, Massachusetts
    3   Insitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts
    4   Tufts University School of Medicine, Boston, Massachusetts

  • Elizabeth Yen

    4   Tufts University School of Medicine, Boston, Massachusetts
    5   Tufts Medicine Pediatrics-Boston Children's, Boston, Massachusetts
    6   Mother Infant Research Institute, Tufts Medical Center, Boston, Massachusetts

Funding The research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award no.: UM1TR004398.
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Abstract

Objective

This study aimed to assess the impact of an opt-out consent process compared with the opt-in consent process for using pasteurized donor human milk (PDHM) on feeding practices and growth in preterm neonates.

Study Design

A retrospective study of 200 neonates ≤28 weeks' gestation compared the effects of opt-in versus opt-out consent processes on time to first enteral feed, feeding types, growth trajectories, and prematurity-related morbidities. Descriptive statistics were used to compare the two groups.

Results

The opt-out process did not significantly alter the time to the first enteral feed (range opt-in: 0–12 days vs. opt-out 0–5 days, Mann–Whitney U; p = 0.295). Compared with the opt-in process, the opt-out process was associated with less formula use, less mother's milk use, and more PDHM/mixed mom's milk-PDHM use in the first 4 weeks of life (p < 0.01). Unadjusted analyses showed a greater weight gain in the opt-out group on days of life/DOLs 14 and 28 (2.49 [0.20, 4.78] and 3.94 [0.07, 7.80]%, p < 0.05), and following adjustment, it remained significant for DOL 14 (1.87 [0.02, 3.71]). Prematurity-related morbidities were similar between the two groups.

Conclusion

The opt-out consent process may impart short-term growth benefits in preterm infants. However, long-term outcomes require further study.

Key Points

  • Opt-out is an alternative to the traditional opt-in consent for donor milk use in preterm infants.

  • It is associated with better growth by day 14.

  • Less formula use, and more donor/mixed milk use by day 28.

  • Mother's milk use at discharge and short-term outcomes are similar for both consent types.

  • Future studies will focus on the long-term effects and benefits of the opt-out consent process.

Keywords

pasteurized donor human milk - breast milk - opt-in consent - opt-out consent - feeding - growth - short-term morbidities

Authors' Contributions

E.Y.: Conceptualization and design of the study, implementation, and supervision of the study. C.C.G. and E.Y.: EMR review and extraction of the data and interim data analysis for abstract submission. M.S.: Consultation on statistical methods and final analysis of the entire dataset. C.C.G.: Writing—original draft preparation. C.C.G., M.S., and E.Y.: Editing and revision of the draft. All authors contributed to the final article and approved the submitted version.


Supplementary Material



Publication History

Received: 25 January 2025

Accepted: 30 May 2025

Accepted Manuscript online:
02 June 2025

Article published online:
24 June 2025

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