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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

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
› Author Affiliations
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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