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Oral Colostrum and Its Effect on Immune System

NCT03578341 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-10-02

No results posted yet for this study

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

Conditions

  • Immune System Diseases
  • Premature Infant Disease
  • Immunoglobulin Deficiency

Interventions

BIOLOGICAL

Orally Colostrum

Group 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.

Sponsors & Collaborators

  • Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

    lead OTHER_GOV

Principal Investigators

  • Martha Morelos-Gonzalez, Chem · Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

  • Diana M Soriano-Becerril, MSc · Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

  • Jorge A Cardona-Pérez, MD · Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

  • Araceli Montoya-Estrada, PhD · Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

  • Elsa Castro-Millán, Thec · Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

  • Enrique Segura -Cervantes, MSc · Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Hours
Max Age
36 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-10-30
Completion
2019-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03578341 on ClinicalTrials.gov