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Oral Colostrum and Its Effect on Immune System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03578341
Recruitment Status : Active, not recruiting
First Posted : July 6, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Silvia Romero-Maldonado, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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

Condition or disease Intervention/treatment Phase
Immune System Diseases Premature Infant Disease Immunoglobulin Deficiency Biological: Orally Colostrum Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Prevention
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.
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Quantification of serum Immunoglobulins [ Time Frame: From baseline to day 7 ]
    Quantification of immunoglobulins IgA, IgG and IgM


Secondary Outcome Measures :
  1. sepsis neonatal [ Time Frame: 28 days of postnatal age ]
    Frequency of neonatal sepsis

  2. Necrotising Enterocolitis [ Time Frame: 28 days of postnatal age ]
    Frequency of neonatal

  3. Quantification of serum Immunoglobulins [ Time Frame: From baseline to day 28 ]
    Quantification of immunoglobulins IgA, IgG and IgM



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578341


Locations
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Mexico
Guadalupe del Carmen Estrada-Gutierrez
Miguel Hidalgo, Ciudad DE México, Mexico, 11000
Silvia Romero-Maldonado
Miguel Hidalgo, Ciudad DE México, Mexico, 11000
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Investigators
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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
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Responsible Party: Silvia Romero-Maldonado, NEONATOLOGIST, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier: NCT03578341    
Other Study ID Numbers: 212250-2320-10305-01-16
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patients will be registered in a SPSS database
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The Data will be available in 2019, after the protocol is finished, for a month

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silvia Romero-Maldonado, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
Immunoglobulins A, G and M
Neonatal Sepsis
Human Milk
Orally Colostrum
Additional relevant MeSH terms:
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Premature Birth
Infant, Premature, Diseases
Immune System Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases