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Randomized Controlled Trial of Oropharyngeal Colostrum Administration in Very-low-birth-weight Preterm Infants

Ferreira, Daniela M.L.M.*; Oliveira, Angela M.M.; de Leves, Débora V.; de Bem, Érica B.; Fatureto, Giovana G.; Navarro, Natássia F.; Afonso, Nathália G.; Santiago, Fernanda M.§; Mineo, José R.§; Sopelete, Mônica C.§; Martinez, Francisco E.||; Bernardino Neto, Morun; Abdallah, Vânia O.S.*

Journal of Pediatric Gastroenterology and Nutrition: July 2019 - Volume 69 - Issue 1 - p 126–130
doi: 10.1097/MPG.0000000000002356
Original Articles: Nutrition

Objective: The purpose of this study was to evaluate the effects of oropharyngeal colostrum administration in the incidence of late-onset clinical and proven sepsis and in concentrations of immunoglobulin A (IgA) in very-low-birth-weight (VLBW) infants.

Methods: We conducted a double-blinded, randomized, placebo-controlled trial and assigned 113 VLBW infants to receive 0.2 mL of maternal colostrum or sterile water (placebo) via oropharyngeal route every 2 hours for 48 hours, beginning in the first 48 to 72 hours of life. Neonates of both groups were fed breast milk from the first 3 days of life until a volume of at least 100 mL · kg−1 · day−1. IgA was measured in serum and urine before and after treatment. Clinical data during hospitalization were collected.

Results: We found no statistically significant differences between colostrum and placebo groups in the incidence of late-onset clinical sepsis (odds ratio 0.7602; CI 95% 0.3–1.6) and proven sepsis (odds ratio 0.7028; CI 95% 0.3–1.6). The measurement of IgA was similar in serum before (P value 0.87) and after treatment (P value 0.26 day 4 and 0.77 day 18). No differences were also observed in IgA in urine before (P value 0.8) and after treatment (P value 0.73 day 4 and 0.52).

Conclusions: This study could not confirm the hypothesis that oropharyngeal administration of maternal colostrum to VLBW could reduce the incidence of late-onset sepsis and increase the levels of IgA. We believe that this finding can be justified by the practice of feeding VLBW infants exclusively with breast milk in the first days of life and reinforces the prior knowledge of the importance of early nutrition, especially, with human milk. It also suggests that oropharyngeal administration of colostrum should be reserved for neonates who cannot be fed in first few days of life.

*Division of Neonatology, Department of Pediatrics

Human Milk Bank, Clinics Hospital

Faculty of Medicine

§Laboratory of Immunology, Biological Science Institute, Federal University of Uberlândia, Minas Gerais, Uberlândia

||Division of Neonatology, Department of Pediatrics, University of São Paulo, Ribeirão Preto, São Paulo

Engineering School, University of São Paulo, Lorena, Sao Paulo, Brazil.

Address correspondence and reprint requests to Daniela M.L.M. Ferreira, PhD, Division of Neonatology, Department of Pediatrics, Federal University of Uberlândia, Av. Pará 1720, Uberlândia, MG/CEP 38405-320, Brazil (e-mail:

Received 25 April, 2018

Accepted 11 March, 2019 Registration number: NCT02912585.

The study was financially supported by Foundation for Research Support of Minas Gerais (FAPEMIG).

The authors report no conflicts of interest.

© 2019 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,