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 grou
p
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.
El diseño ideal para estimar los efectos de intervenciones es un ensayo clínico con asignación aleatoria (AA), en los que esta AA a la intervención, equilibra características observadas y no ...observadas de los sujetos que componen los grupos en estudio.Si no se puede realizar AA, existe una alternativa para controlar sesgos, conocida como puntajes de propensión (PP).Los PP son útiles para estimar el efecto de una intervención o exposición sobre un resultado en estudios observacionales, especialmente cuando se estima la posibilidad que existan sesgos de confusión y selección debido a una asignación de tratamiento no aleatoria. Son una técnica de emparejamiento avanzada de variables de confusión como edad, sexo, etc., permitiendo que se puedan comparar pacientes de edad similar en grupos de intervención y de comparación. Esto, se puede complejizar si se decide agregar muchas variables al proceso de emparejamiento (edad, sexo, etnia, nivel educacional), puesto que será difícil encontrar coincidencias exactas para los sujetos. Entonces, los PP resuelven este problema de dimensionalidad comprimiendo factores relevantes en un solo puntaje, así, los pacientes con PP similares se comparan entre los grupos de intervención y comparación.El objetivo de este manuscrito fue generar un documento de estudio referente al uso de los PP y su rol en investigación quirúrgica.
IntroductionThe mother's colostrum carries immunological components, such as cytokines and immunoglobulins (Igs), derived from the maternal circulation with bacteriostatic properties. ObjectiveThe ...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. HypothesisThe OPAC increases serum Igs and decreases morbidity and total days of hospitalization. Materials and MethodsA 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). ConclusionIn 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 Registrationhttps://clinicaltrials.gov/ct2/show/NCT03578341, identifier: NCT03578341.
