Oral Colostrum and Its Effect on Immune System

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03578341
• Other study ID #: 212250-2320-10305-01-16
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2019
• Source: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: December 31, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 36 Hours

Eligibility

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

Related Conditions & MeSH terms

• Immune System Diseases
• Immunoglobulin Deficiency
• Infant, Premature, Diseases
• Premature Birth
• Premature Infant Disease

Intervention

Biological:
• Orally Colostrum
Group 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.

Locations

Country	Name	City	State
Mexico	Guadalupe del Carmen Estrada-Gutierrez	Miguel Hidalgo	Ciudad DE México
Mexico	Silvia Romero-Maldonado	Miguel Hidalgo	Ciudad DE México

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of serum Immunoglobulins	Quantification of immunoglobulins IgA, IgG and IgM	From baseline to day 7
Secondary	sepsis neonatal	Frequency of neonatal sepsis	28 days of postnatal age
Secondary	Necrotising Enterocolitis	Frequency of neonatal	28 days of postnatal age
Secondary	Quantification of serum Immunoglobulins	Quantification of immunoglobulins IgA, IgG and IgM	From baseline to day 28