Immune System Diseases Clinical Trial
Official title:
Effect of Early Oral Colostrum Administration Versus Placebo on the Immune System in Premature Newborns Under 32 Weeks of Gestation: A Randomized Clinical Trial.
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo
Prematurity is a public health problem because premature newborns have an immature immune
system. Breast milk (colostrum) contains bioactive components that provide antimicrobial,
anti-inflammatory, antioxidant, and immunomodulatory functions. These bioactive components
are in higher concentrations in mothers' colostrum of premature babies. Because of the
morbidities presented by premature infants, they remain fasting and lack the potential
benefit provided by colostrum. When the colostrum is placed in the oropharyngeal mucosa, the
immunocompetent cells stimulate the immune system, increasing the serum concentrations of
immunoglobulins.
Objectives: To determine the efficacy of early administration of colostrum in the
oropharyngeal mucosa in preterm infants less than 32 weeks of gestation and its effect on the
immune system by quantifying immunoglobulins in preterm infants born at the National
Institute of Perinatology. .
Methods / Design: 1 year, double blind randomized controlled clinical trial. The newborns
included will be randomly assigned to one of the 2 groups: Group 1:, newborns receiving
colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.
Newborns from Block B will receive orally sterile water (placebo) 0.3 mL following the same
protocol. Serum immunoglobulin A, M and G concentrations will be determined before the start
of the study on day 0 of life and after 7 and 28 days of life. They will continue in time
until 36 SDG or at discharge, whichever comes first.
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