Oral Colostrum and Its Effect on Immune System

Phase 3

• Conditions: Immunoglobulin Deficiency; Premature Infant Disease; Immune System Diseases
• Interventions: Biological: Orally Colostrum

• Registration Number: NCT03578341
• Lead Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Brief 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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-06-22
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-06
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02
• Primary Completion: 2019-10-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• NEWBORN 32 Gestational weeks
• Hospitalized in neonatal intensive care Unit
• Agreement signed by the legal representative

Exclusion Criteria

• Intraventricular haemorrhage II/IV grade
• Congenital sepsis (early sepsis)
• Congenital malformations
• Early transfusions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Colostrum	Orally Colostrum	Group 1:(Colostrum): Preterm infants under 32 SDG will receive orally colostrum 0.3 mL every 4 h during three days.
Placebo	Orally Colostrum	Group 2: (Placebo): Preterm newborns under 32 SDG who will receive orally sterile water 0.3 mL every 4 h during three days.

Primary Outcome Measures

Name	Time	Method
Quantification of serum Immunoglobulins	From baseline to day 7	Quantification of immunoglobulins IgA, IgG and IgM

Secondary Outcome Measures

Name	Time	Method
sepsis neonatal	28 days of postnatal age	Frequency of neonatal sepsis
Quantification of serum Immunoglobulins	From baseline to day 28	Quantification of immunoglobulins IgA, IgG and IgM
Necrotising Enterocolitis	28 days of postnatal age	Frequency of neonatal

Trial Locations

Locations (2)

Guadalupe del Carmen Estrada-Gutierrez; 🇲🇽 Miguel Hidalgo, Ciudad DE México, Mexico

Silvia Romero-Maldonado; 🇲🇽 Miguel Hidalgo, Ciudad DE México, Mexico