Immune System Diseases, Immunoglobulin Deficiency, Premature Infant Disease
Conditions
Keywords
Immunoglobulins A, G and M, Neonatal Sepsis, Human Milk, Orally Colostrum
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.
Interventions
BIOLOGICALOrally Colostrum
Group 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.
Sponsors
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
12 Hours to 36 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of serum Immunoglobulins | From baseline to day 7 | Quantification of immunoglobulins IgA, IgG and IgM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sepsis neonatal | 28 days of postnatal age | Frequency of neonatal sepsis |
| Necrotising Enterocolitis | 28 days of postnatal age | Frequency of neonatal |
| Quantification of serum Immunoglobulins | From baseline to day 28 | Quantification of immunoglobulins IgA, IgG and IgM |
Countries
Mexico
Outcome results
None listed