Oral Colostrum and Its Effect on Immune System

October 1, 2019 updated by: Silvia Romero-Maldonado, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Ciudad DE México
      • Miguel Hidalgo, Ciudad DE México, Mexico, 11000
        • Guadalupe del Carmen Estrada-Gutierrez
      • Miguel Hidalgo, Ciudad DE México, Mexico, 11000
        • Silvia Romero-Maldonado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 hours to 1 day (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Colostrum
Group 1:(Colostrum): Preterm infants under 32 SDG will receive orally colostrum 0.3 mL every 4 h during three days.
Biological: Orally Colostrum
Group 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.
PLACEBO_COMPARATOR: Placebo
Group 2: (Placebo): Preterm newborns under 32 SDG who will receive orally sterile water 0.3 mL every 4 h during three days.
Biological: Orally Colostrum
Group 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of serum Immunoglobulins
Time Frame: From baseline to day 7
Quantification of immunoglobulins IgA, IgG and IgM
From baseline to day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sepsis neonatal
Time Frame: 28 days of postnatal age
Frequency of neonatal sepsis
28 days of postnatal age
Necrotising Enterocolitis
Time Frame: 28 days of postnatal age
Frequency of neonatal
28 days of postnatal age
Quantification of serum Immunoglobulins
Time Frame: From baseline to day 28
Quantification of immunoglobulins IgA, IgG and IgM
From baseline to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Investigators

  • Study Chair: Martha Morelos-Gonzalez, Chem, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  • Study Chair: Diana M Soriano-Becerril, MSc, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  • Study Chair: Jorge A Cardona-Pérez, MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  • Study Chair: Araceli Montoya-Estrada, PhD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  • Study Chair: Elsa Castro-Millán, Thec, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  • Study Chair: Enrique Segura -Cervantes, MSc, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ANTICIPATED)

October 30, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

June 22, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (ACTUAL)

July 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212250-2320-10305-01-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patients will be registered in a SPSS database

IPD Sharing Time Frame

The Data will be available in 2019, after the protocol is finished, for a month

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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