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Randomized Controlled Trial
. 2023 May;43(5):601-607.
doi: 10.1038/s41372-022-01589-x. Epub 2023 Jan 3.

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

Nancy A Rodriguez  1   2 , Fernando Moya  3 , John Ladino  4 , Adel Zauk  5 , Preetha Prazad  6 , Jorge Perez  7 , Maximo Vento  8 , Erika Claud  2 , Chi-Hsiung Wang  1   2 , Michael S Caplan  9   10
Affiliations
Randomized Controlled Trial

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

Nancy A Rodriguez et al. J Perinatol. 2023 May.

Erratum in

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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References

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    1. Rodriguez NA, Meier PP, Groer MW, Zeller JM, Engstrom JL, Fogg L. A pilot study to determine the safety and feasibility of oropharyngeal administration of own mother’s colostrum to extremely low birth weight infants. Adv Neonatal Care. 2010;10:206–12. - DOI - PubMed - PMC
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    1. Rodriguez NA, Groer MW, Zeller JM, Engstrom JL, Fogg L, Du H, et al. A randomized clinical trial of the oropharyngeal administration of mother’s colostrum to extremely low birth weight infants in the first days of life. Neonatal Intensive Care. 2011;24:31–35.
    1. Thibeau S, Boudreaux C. Exploring the use of mother’s own milk as oral care for mechanically ventilated very low birth weight infants. Adv Neonatal Care. 2013;13:190–7. - DOI - PubMed

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