TY - JOUR
T1 - Effect of Oropharyngeal Administration of Colostrum in Premature Newborns ≤32 Weeks of Gestation on the Immune Response and Neonatal Morbidity
T2 - A Double-Blind Randomized Clinical Trial
AU - Romero-Maldonado, Silvia
AU - Soriano-Becerril, Diana Mercedes
AU - García-May, Perla Karina
AU - Reyes-Muñoz, Enrique
AU - Muñoz-Ortíz, Eudoxia Georgina
AU - Carrera-Muiños, Sandra
AU - Granados-Cepeda, Martha Lucía
AU - Cardona-Pérez, Jorge Arturo
AU - Castro-Millán, Elsa
AU - Segura-Cervantes, Enrique
AU - Ceballos, Guillermo
AU - Montoya-Estrada, Araceli
N1 - Publisher Copyright:
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.
PY - 2022/7/8
Y1 - 2022/7/8
N2 - 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://clinicaltrials.gov/ct2/show/NCT03578341], identifier: [NCT03578341].
AB - 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://clinicaltrials.gov/ct2/show/NCT03578341], identifier: [NCT03578341].
KW - colostrum
KW - immunoglobulins
KW - mortality of premature
KW - neonatal sepsis
KW - premature
KW - tolerance to the enteral route
UR - http://www.scopus.com/inward/record.url?scp=85134660098&partnerID=8YFLogxK
U2 - 10.3389/fped.2022.891491
DO - 10.3389/fped.2022.891491
M3 - Artículo
C2 - 35874579
AN - SCOPUS:85134660098
SN - 2296-2360
VL - 10
JO - Frontiers in Pediatrics
JF - Frontiers in Pediatrics
M1 - 891491
ER -