Oral Colostrum and Its Effect on Immune System

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Status and phase: Unknown; Phase 3

Conditions: Immunoglobulin Deficiency; Premature Infant Disease; Immune System Diseases

Treatments: Biological: Orally Colostrum

Study type: Interventional

Funder types: Other

Identifiers

NCT03578341

212250-2320-10305-01-16

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 12 to 36 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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96 participants in 2 patient groups, including a placebo group

Colostrum

Experimental group

Description:

Group 1:(Colostrum): Preterm infants under 32 SDG will receive orally colostrum 0.3 mL every 4 h during three days.

Treatment:

Biological: Orally Colostrum

Placebo

Placebo Comparator group

Description:

Group 2: (Placebo): Preterm newborns under 32 SDG who will receive orally sterile water 0.3 mL every 4 h during three days.

Treatment:

Biological: Orally Colostrum