Metagenomic analysis of the colony of bacteria from the intestine of premature babies undergoing treatment with Colostrotherapy treated by the Unified Health System (SUS): Intervention Study

Not Applicable

• Conditions: Other Specific bowel diseases; preterm newborn; K63.8; P07.3

• Registration Number: RBR-3mm7cs
• Lead Sponsor: Jessica Santos Passos Costa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

The inclusion criteria for the control group (from HEC) will be: premature newborns
admitted to Neonatal Units, birth weight 1,500g, 32 weeks gestational age, They must be on a zero diet orally and enteral or using total parenteral nutrition (NTP), and / or enteral administration of infant formula and clinically stable, with normal parameters. In addition, to collect the fecal sample, the newborn will be included if the first evacuation was made at the NICU. The mothers of infants, both for the group of intervention, as well as for the control group, will be selected according to the eligibility criteria of your children's entry into the study

Exclusion Criteria

Among the exclusion criteria: mother's, maternal history of substance use psychoactive drugs, drugs, alcohol, presence of
psychological disorder, multiple pregnancy from triplets and children of mothers contraindicated for breastfeeding retroviruses and cytomegalovirus). RN: use of vasopressor medication bigger then 10mcg / Kg / min, requirement for immediate surgical intervention, syndromes and / or congenital malformations, neonatal morbidities such as the incidence of patent ductus arteriosus (PDA), sepsis or necrotizing enterocolitis (NEC), The newborn who eliminates meconium in the Obstetric Center (CO).

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the association, through metagenomic analysis, between immunotherapy with<br>colostrum and the intestinal microbiome colonized by bacterial species in premature newborns treated at the Unified Health System in Feira de Santana - BA

Secondary Outcome Measures

Name	Time	Method
Describe the birth, socioeconomic and environmental variables of newborns<br>born and their mothers, in the intervention and control group;Investigate the differences between the microbiome infection of preterm infants treated or not with colostrum;Examine the diversity of bacteria<br>present in meconium and on the fifth day of life, through metagenomic DNA, of newborns<br>preterm infants treated or not with colostrum;Assess the immunological profile of preterm infants treated or not with colostrum;Compare the occurrence of unfavorable outcomes (any diagnosis of health conditions of<br>newborns) between groups