Effect of Oropharyngeal Administration of Colostrum in Premature Newborns ≤32 Weeks of Gestation on the Immune Response and Neonatal Morbidity: A Double-Blind Randomized Clinical Trial

Abstract

Introduction: The mother's colostrum carries immunological components, such as cytokines and immunoglobulins (Igs), derived from the maternal circulation with bacteriostatic properties.

Objective: The objective of this study was to evaluate the effect of oropharyngeal administration of colostrum (OPAC) vs. placebo in the first 4 days of life in premature newborns ≤32 weeks of gestation on serum Ig concentration, neonatal morbidity, and total days of hospitalization.

Hypothesis: The OPAC increases serum Igs and decreases morbidity and total days of hospitalization.

Materials and methods: A double-blind randomized controlled trial was carried out. Participants were randomly assigned to one of the two groups, namely, group 1: placebo (P) (n = 50) and group 2: colostrum (C) (n = 46). A blood sample was obtained at baseline and 7 and 28 days of life to quantify immunoglobulin G (IgG), immunoglobulin A (IgA), and IgM. Results: The C group showed an increase in serum IgA on day 28 expressed as median and [interquartile range]; C: 25 [12-35] vs. P: 11 [8-18], p < 0.001. There were no significant differences in neonatal morbidity. Newborns in the colostrum group showed the completed enteral feeding earlier (days), C: 13.9 ± 7 vs. P: 17.4 ± 8.4, p < 0.04; they reached the birth weight earlier, C: 10.9 ± 2.8 vs. P: 12.9 ± 4, p < 0.01, and had less days of hospitalization, C: 60.2 ± 33.8 vs. P: 77.2 ± 47.3, p < 0.04. Neonatal mortality was lower in the colostrum group than the placebo group 0% vs. 12%, respectively, without a statistical difference (p = 0.06).

Conclusion: In premature newborns ≤32 weeks of gestation, the OPAC within 4 days after birth increases serum IgA concentration at day 28 compared to placebo. Similarly, OPAC decreased the days to complete enteral feeding and reach the birth weight and total days of hospitalization.

Clinical trial registration: [https://ichgcp.net/clinical-trials-registry/NCT03578341], identifier: [NCT03578341].

Keywords: colostrum; immunoglobulins; mortality of premature; neonatal sepsis; premature; tolerance to the enteral route.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Romero-Maldonado, Soriano-Becerril, García-May, Reyes-Muñoz, Muñoz-Ortíz, Carrera-Muiños, Granados-Cepeda, Cardona-Pérez, Castro-Millán, Segura-Cervantes, Ceballos and Montoya-Estrada.

Figures

Figure 1

Flow diagram for participants included in the study.

Figure 2

Intragroup comparison of serum immunoglobulin levels at basal, day 7, and day 28. *p < 0.05, **p < 0.001, ***p < 0.0001. (A) There was a significant decrease in the intragroup concentration of IgG from basal to day 28 in both groups. (B) There was a significant increase in the intragroup concentration of IgM from basal to day 28 in both groups. (C) There was a significant increase in the intragroup concentration of IgA from basal to days 7 and 28, respectively, in the colostrum group, while in the placebo group, there was no significant decrease of IgA from basal to day 28.