Oral Colostrum and Its Effect on Immune System

NCT03578341 | Unknown Phase 3 DMC

• 1 other identifier: 212250-2320-10305-01-16
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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

Conditions

Immune System Diseases; Premature Infant Disease; Immunoglobulin Deficiency

Keywords

Immunoglobulins A, G and M; Neonatal Sepsis; Human Milk; Orally Colostrum

Outcome Measures

Primary Outcomes (1)

• Quantification of serum Immunoglobulins

  Quantification of immunoglobulins IgA, IgG and IgM

  From baseline to day 7

Secondary Outcomes (3)

• sepsis neonatal

  28 days of postnatal age

• Necrotising Enterocolitis

  28 days of postnatal age

• Quantification of serum Immunoglobulins

  From baseline to day 28

Study Arms (2)

Colostrum

EXPERIMENTAL

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

Biological: Orally Colostrum

Placebo

PLACEBO COMPARATOR

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

Interventions

Orally Colostrum BIOLOGICAL

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

Colostrum; Placebo

Eligibility Criteria

• Age: 12 Hours - 36 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes: lead

Study Sites (2)

Guadalupe del Carmen Estrada-Gutierrez

Miguel Hidalgo, Mexico City, 11000, Mexico

Location

Silvia Romero-Maldonado

Miguel Hidalgo, Mexico City, 11000, Mexico

Location

Related Publications (1)

• Romero-Maldonado S, Soriano-Becerril DM, Garcia-May PK, Reyes-Munoz E, Munoz-Ortiz EG, Carrera-Muinos S, Granados-Cepeda ML, Cardona-Perez JA, Castro-Millan E, Segura-Cervantes E, Ceballos G, Montoya-Estrada A. Effect of Oropharyngeal Administration of Colostrum in Premature Newborns </=32 Weeks of Gestation on the Immune Response and Neonatal Morbidity: A Double-Blind Randomized Clinical Trial. Front Pediatr. 2022 Jul 8;10:891491. doi: 10.3389/fped.2022.891491. eCollection 2022.

  PMID: 35874579 DERIVED

MeSH Terms

Conditions

Immune System Diseases; Agammaglobulinemia; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunologic Deficiency Syndromes; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Masking Description: The colostrum and placebo will be preparing by a Human Milk Bank person, who will be knowing the treatment of both 2nd and 1st group. Both colostrum and placebo, will be administrating by nursing staff in syringes in such a way that it is not detected that it contains each of them. Neither the parents of the participants nor the researchers will be involved in the care or analysis of the data, until the end of the study.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NEONATOLOGIST

Model Details: Intervention Model Description: The Participants will be randomly and assigned to Group 1, or Group 2 . using a table of random numbers, generated by a computer. The Human Milk Bank Staff, will prepares the colostrum and water (placebo) doses in syringes in such a way that it is not detected that it contains each of them, . Group 1: Will receive 0.3 mL orally colostrum every 4 h during three days, Group 2: will receive 0.3 mL orally Sterile water. Serum immunoglobulins A, G and M concentration will be determined before de start the orally doses, day 7 and 28 days of life.he nurse in charge of the patient's care, administer the dose, a doctor will take the laboratory exams and another researcher will collect and analyze the data. The syringes will be covered, to prevent the patiente´s nurse from observing the contents.

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 6, 2018
• Study Start: June 1, 2018
• Primary Completion: October 30, 2019
• Study Completion: December 31, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The Data will be available in 2019, after the protocol is finished, for a month

Locations

ME (2)