NCT03578341

Oral Colostrum and Its Effect on Immune System

Effect of Early Oral Colostrum Administration Versus Placebo on the Immune System in Premature Newborns Under 32 Weeks of Gestation: A Randomized Clinical Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes · Other Government
• Sex: All
• Age: 12 Hours – 36 Hours
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Immune System Diseases
• Premature Infant Disease
• Immunoglobulin Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Orally Colostrum	Group 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-10-30
• Completion: 2019-12-31
• First posted: 2018-07-06
• Last updated: 2019-10-02

Locations

2 sites across 1 country: Mexico