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A randomized controlled trial of oropharyngeal therapy with mother’s own milk for premature infants

Journal of Perinatology volume 43, pages 601–607 (2023)Cite this article

Subjects

A Correction to this article was published on 16 January 2023

This article has been updated

Abstract

Objective

To determine if oropharyngeal therapy with mother’s own milk (OPT-MOM) reduces late-onset sepsis (L-OS; primary outcome), NEC, death, length of stay, time to full enteral nutrition (FEN) and full oral feeds in preterm infants (BW < 1250 g).

Design

Infants (N = 220) were randomized to Group A (milk) or B (placebo) and received 0.2 mL every 2 h for 48 h, then every 3 h until 32 weeks CGA.

Results

There were no significant differences in L-OS, NEC or death. Group A trended towards an 8-day reduction in stay, 8-day reduction in time to FEN and a 6-day reduction in time to full oral feeds, compared to B. While clinically relevant, due to large variability in outcomes and lack of power, p values were > 0.05.

Conclusion

OPT-MOM did not reduce L-OS, NEC or death. Group A trended towards a reduced stay and better nutritional outcomes, but results were not statistically significant.

ClinicalTrials.gov

NCT02116699.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Change history

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Funding

Supported by a grant from the Gerber Foundation (primary study sponsor-grant number 3877), the Associate Board of NorthShore University HealthSystem and an Anonymous Donor.

Author information

Author notes

  1. Deceased: Nancy A. Rodriguez.

Authors and Affiliations

  1. Department of Pediatrics, NorthShore University HealthSystem, Evanston, IL, USA

    Nancy A. Rodriguez, Chi-hsiung Wang & Michael S. Caplan

  2. University of Chicago Pritzker School of Medicine, Chicago, IL, USA

    Nancy A. Rodriguez, Erika Claud, Chi-hsiung Wang & Michael S. Caplan

  3. Department of Pediatrics, UNC School of Medicine, Chapel Hill, NC, USA

    Fernando Moya

  4. Department of Pediatrics, Goryeb Children’s Hospital, Morristown, NJ, USA

    John Ladino

  5. Neonatology, St Joseph’s Children’s Hospital, Paterson, NJ, USA

    Adel Zauk

  6. Neonatology, Advocate Children’s Hospital-Park Ridge, Park Ridge, IL, USA

    Preetha Prazad

  7. Department of Pediatrics, South Miami Hospital, Coral Gables, FL, USA

    Jorge Perez

  8. Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain

    Maximo Vento

Authors
  1. Nancy A. Rodriguez
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Contributions

Conception and design of the study: NAR, MSC, MV, EC, CW. Acquisition of data: FM, JL, AZ, PP, JP. Analysis and interpretation of data: CW, MSC. Drafting of manuscript: NAR. Critical revision and final approval of the version to be published: all authors.

Corresponding author

Correspondence to Michael S. Caplan.

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Competing interests

The authors declare no competing interests.

Consent statement

Patient consent was required for this study. The subjects (infants) were enrolled in the study only after voluntary informed consent was obtained from the parents.

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The original online version of this article was revised: The author’s name John Ladino has been corrected.

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Rodriguez, N.A., Moya, F., Ladino, J. et al. A randomized controlled trial of oropharyngeal therapy with mother’s own milk for premature infants. J Perinatol 43, 601–607 (2023). https://doi.org/10.1038/s41372-022-01589-x

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