Clinical trial NCT03578341: Oral Colostrum and Its Effect on Immune System
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Immune System Diseases
Premature Infant Disease
Immunoglobulin Deficiency
Keywords: Immunoglobulins A, G and M
Neonatal Sepsis
Human Milk
Orally Colostrum
Lead sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Sponsor class: OTHER_GOV
First posted: 2018-07-06
Enrollment: 96
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: Quantification of serum Immunoglobulins
timeFrame: From baseline to day 7
Secondary outcomes:
measure: sepsis neonatal
timeFrame: 28 days of postnatal age
measure: Necrotising Enterocolitis
timeFrame: 28 days of postnatal age
measure: Quantification of serum Immunoglobulins
timeFrame: From baseline to day 28
Other outcomes:
Locations:
city: Miguel Hidalgo
country: Mexico
facility: Guadalupe del Carmen Estrada-Gutierrez
state: Ciudad DE México
city: Miguel Hidalgo
country: Mexico
facility: Silvia Romero-Maldonado
state: Ciudad DE México
Study officials:
affiliation: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
name: Martha Morelos-Gonzalez, Chem
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
name: Diana M Soriano-Becerril, MSc
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
name: Jorge A Cardona-Pérez, MD
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
name: Araceli Montoya-Estrada, PhD
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
name: Elsa Castro-Millán, Thec
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
name: Enrique Segura -Cervantes, MSc
role: STUDY_CHAIR
References:
citation: 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.