Download PDF
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.
› Further Information
Also available at
   Permissions and Reprints

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

© 2025. Thieme. All rights reserved.

Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA

 

  • References

  • 1 Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics 2012; 129 (03) e827-e841
    CrossrefPubMedSearch in Google Scholar
  • 2 Meek JY, Noble L. Section on Breastfeeding. Section on breastfeeding. Policy statement: breastfeeding and the use of human milk. Pediatrics 2022; 150 (01) e2022057988
    CrossrefPubMedSearch in Google Scholar
  • 3 Breastfeeding. Accessed October 16, 2024 at: https://www.who.int/health-topics/breastfeeding
    PubMed
  • 4 Parker MG, Stellwagen LM, Noble L, Kim JH, Poindexter BB, Puopolo KM. SECTION ON BREASTFEEDING, COMMITTEE ON NUTRITION, COMMITTEE ON FETUS AND NEWBORN. Promoting human milk and breastfeeding for the very low birth weight infant. Pediatrics 2021; 148 (05) e2021054272
    CrossrefPubMedSearch in Google Scholar
  • 5 Committee on nutrition, Section on breastfeeding, Committee on fetus and newborn. Donor human milk for the high-risk infant: preparation, safety, and usage options in the United States. Pediatrics 2017; 139 (01) e20163440
    CrossrefPubMedSearch in Google Scholar
  • 6 Kashyap V, Choudhari SG. Unlocking the potential: a systematic literature review on the impact of donor human milk on infant health outcomes. Cureus 2024; 16 (04) e57440
    PubMedSearch in Google Scholar
  • 7 Patel AL, Kim JH. Human milk and necrotizing enterocolitis. Semin Pediatr Surg 2018; 27 (01) 34-38
    PubMedSearch in Google Scholar
  • 8 Kreissl A, Sauerzapf E, Repa A. et al. Starting enteral nutrition with preterm single donor milk instead of formula affects time to full enteral feeding in very low birthweight infants. Acta Paediatr 2017; 106 (09) 1460-1467
    CrossrefPubMedSearch in Google Scholar
  • 9 Gustafsson A, Johansson E, Henckel E. et al. Antisecretory factor in breastmilk is associated with reduced incidence of sepsis in preterm infants. Pediatr Res 2024; 95 (03) 762-769
    PubMedSearch in Google Scholar
  • 10 Verd S, Porta R, Ginovart G. et al. Human milk feeding is associated with decreased incidence of moderate-severe bronchopulmonary dysplasia in extremely preterm infants. Children (Basel) 2023; 10 (07) 1267
    PubMedSearch in Google Scholar
  • 11 Bharwani SK, Green BF, Pezzullo JC, Bharwani SS, Bharwani SS, Dhanireddy R. Systematic review and meta-analysis of human milk intake and retinopathy of prematurity: a significant update. J Perinatol 2016; 36 (11) 913-920
    PubMedSearch in Google Scholar
  • 12 Belfort MB, Knight E, Chandarana S. et al. Associations of maternal milk feeding with neurodevelopmental outcomes at 7 years of age in former preterm infants. JAMA Netw Open 2022; 5 (07) e2221608
    CrossrefPubMedSearch in Google Scholar
  • 13 Konnikova Y, Zaman MM, Makda M, D'Onofrio D, Freedman SD, Martin CR. Late enteral feedings are associated with intestinal inflammation and adverse neonatal outcomes. PLoS One 2015; 10 (07) e0132924
    PubMedSearch in Google Scholar
  • 14 Valentine CJ, Dumm M. Pasteurized donor human milk use in the neonatal intensive care unit. Neoreviews 2015; 16 (03) e152-e159
    PubMedSearch in Google Scholar
  • 15 Sharma R, Hudak ML. A clinical perspective of necrotizing enterocolitis: past, present, and future. Clin Perinatol 2013; 40 (01) 27-51
    PubMedSearch in Google Scholar
  • 16 Sullivan S, Schanler RJ, Kim JH. et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr 2010; 156 (04) 562-7.e1
    CrossrefPubMedSearch in Google Scholar
  • 17 COMMITTEE ON BIOETHICS. Informed consent in decision-making in pediatric practice. Pediatrics 2016; 138 (02) e20161484
    PubMedSearch in Google Scholar
  • 18 Beauchamp T, Childress J. Principles of biomedical ethics: marking its fortieth anniversary. Am J Bioeth 2019; 19 (11) 9-12
    CrossrefPubMedSearch in Google Scholar
  • 19 Junghans C, Feder G, Hemingway H, Timmis A, Jones M. Recruiting patients to medical research: double blind randomised trial of “opt-in” versus “opt-out” strategies. BMJ 2005; 331 (7522): 940
    PubMedSearch in Google Scholar
  • 20 Berry JG, Ryan P, Gold MS, Braunack-Mayer AJ, Duszynski KM. Vaccine Assessment Using Linked Data (VALiD) Working Group. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage. J Med Ethics 2012; 38 (10) 619-625
    PubMedSearch in Google Scholar
  • 21 Fernandes DM, Roland AP, Morris MC. Parental opinions regarding an opt-out consent process for inpatient pediatric prospective observational research in the US. Pragmat Obs Res 2017; 8: 1-8
    PubMedSearch in Google Scholar
  • 22 Vestager ML, Hansen ML, Greisen G. SafeBoosC-III trial group. Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III. Trials 2024; 25 (01) 236
    PubMedSearch in Google Scholar
  • 23 den Boer MC, Houtlosser M, Foglia EE. et al. Deferred consent for delivery room studies: the providers' perspective. Arch Dis Child Fetal Neonatal Ed 2020; 105 (03) 310-315
    PubMedSearch in Google Scholar
  • 24 Katheria A, Schmölzer GM, Janvier A. et al. A narrative review of the rationale for conducting neonatal emergency studies with a waived or deferred consent approach. Neonatology 2023; 120 (03) 344-352
    PubMedSearch in Google Scholar
  • 25 Sawtell M, van Blankenstein E, Bilal T. et al. Views of parents, adults born preterm and professionals on linkage of real-world data of preterm babies. Arch Dis Child Fetal Neonatal Ed 2023; 108 (02) 194-199
    PubMedSearch in Google Scholar
  • 26 Esquerra-Zwiers A, Rossman B, Meier P, Engstrom J, Janes J, Patel A. “It's somebody else's milk”: unraveling the tension in mothers of preterm infants who provide consent for pasteurized donor human milk. J Hum Lact 2016; 32 (01) 95-102
    PubMedSearch in Google Scholar
  • 27 McGlothen-Bell K, Cleveland L, Pados BF. To consent, or not to consent, that is the question: ethical issues of informed consent for the use of donor human milk in the NICU setting. Adv Neonatal Care 2019; 19 (05) 371-375
    PubMedSearch in Google Scholar
  • 28 Walsh MC, Kliegman RM. Necrotizing enterocolitis: treatment based on staging criteria. Pediatr Clin North Am 1986; 33 (01) 179-201
    CrossrefPubMedSearch in Google Scholar
  • 29 Hornik CP, Fort P, Clark RH. et al. Early and late onset sepsis in very-low-birth-weight infants from a large group of neonatal intensive care units. Early Hum Dev 2012; 88 (Suppl. 02) S69-S74
    CrossrefPubMedSearch in Google Scholar
  • 30 Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr 1978; 92 (04) 529-534
    CrossrefPubMedSearch in Google Scholar
  • 31 Shankaran S, Slovis TL, Bedard MP, Poland RL. Sonographic classification of intracranial hemorrhage. A prognostic indicator of mortality, morbidity, and short-term neurologic outcome. J Pediatr 1982; 100 (03) 469-475
    PubMedSearch in Google Scholar
  • 32 Higgins RD, Jobe AH, Koso-Thomas M. et al. Bronchopulmonary dysplasia: executive summary of a workshop. J Pediatr 2018; 197: 300-308
    CrossrefPubMedSearch in Google Scholar
  • 33 Jensen EA, Dysart K, Gantz MG. et al. The diagnosis of bronchopulmonary dysplasia in very preterm infants. An evidence-based approach. Am J Respir Crit Care Med 2019; 200 (06) 751-759
    CrossrefPubMedSearch in Google Scholar
  • 34 Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. New York, NY: Routledge; 2013
    PubMedSearch in Google Scholar
  • 35 Ruys CA, Hollanders JJ, Bröring T. et al. Early-life growth of preterm infants and its impact on neurodevelopment. Pediatr Res 2019; 85 (03) 283-292
    PubMedSearch in Google Scholar
  • 36 Salas AA, Bhatia A, Carlo WA. Postnatal growth of preterm infants 24 to 26 weeks of gestation and cognitive outcomes at 2 years of age. Pediatr Res 2021; 89 (07) 1804-1809
    PubMedSearch in Google Scholar
  • 37 Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth 2016; 16 (01) 90
    CrossrefPubMedSearch in Google Scholar
  • 38 Brown A, Shenker N. Receiving screened donor human milk for their infant supports parental wellbeing: a mixed-methods study. BMC Pregnancy Childbirth 2022; 22 (01) 455
    CrossrefPubMedSearch in Google Scholar
  • 39 Li J, Ip HL, Fan Y, Kwok JY, Fong DY, Lok KYW. Unveiling the voices: Exploring perspectives and experiences of women, donors, recipient mothers and healthcare professionals in human milk donation: a systematic review of qualitative studies. Women Birth 2024; 37 (05) 101644
    PubMedSearch in Google Scholar
  • 40 Increase the proportion of infants who are breastfed exclusively through age 6 months—MICH-15 - Healthy People 2030 | odphp.health.gov . Accessed November 27, 2024 at: https://odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/infants/increase-proportion-infants-who-are-breastfed-exclusively-through-age-6-months-mich-15
    PubMed
  • 41 Carroll K, Herrmann KR. The cost of using donor human milk in the NICU to achieve exclusively human milk feeding through 32 weeks postmenstrual age. Breastfeed Med 2013; 8 (03) 286-290
    PubMedSearch in Google Scholar
  • 42 Stoll BJ, Hansen NI, Bell EF. et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in care practices, morbidity, and mortality of extremely preterm neonates, 1993–2012. JAMA 2015; 314 (10) 1039-1051
    CrossrefPubMedSearch in Google Scholar
  • 43 Talari K, Goyal M. Retrospective studies - utility and caveats. J R Coll Physicians Edinb 2020; 50 (04) 398-402
    PubMedSearch in Google Scholar
  • 44 Kimani-Murage EW, Wanjohi MN, Kamande EW. et al. Perceptions on donated human milk and human milk banking in Nairobi, Kenya. Matern Child Nutr 2019; 15 (04) e12842
    PubMedSearch in Google Scholar
  • 45 Aurich B, Vermeulen E, Elie V. et al. Informed consent for neonatal trials: practical points to consider and a check list. BMJ Paediatr Open 2020; 4 (01) e000847
    PubMedSearch in Google Scholar
  • 46 Jansen-van der Weide MC, Caldwell PHY, Young B. et al. Clinical trial decisions in difficult circumstances: parental consent under time pressure. Pediatrics 2015; 136 (04) e983-e992
    PubMedSearch in Google Scholar
  • 47 McLeish J, Alderdice F, Robberts H, Cole C, Dorling J, Gale C. Members of the WHEAT trial development group. Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents' and health professionals' views and experiences. Arch Dis Child Fetal Neonatal Ed 2021; 106 (03) 244-250
    PubMedSearch in Google Scholar