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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

Metagenomic Analysis of the Intestinal Microbiota of premature infants undergoing treatment with Colostrotherapy treated by the Unified Health System (SUS): Intervention Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3mm7cs
Enrollment
Unknown
Registered
2020-03-25
Start date
2020-04-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Specific bowel diseases

Interventions

Intervention group: 35 extremely premature infants, weighing less than 1,500 g and up to 32 gestational weeks, admitted to the intensive care unit, the mother's own colostrum will be used and the trea
and then the same syringe containing 0.1 ml (two drops) of remaining colostrum will be administered in the left oral mucosal tissue until the twelfth. Fecal sample will be collected on the first and s
Drug
G06.373
Z29.1
H01.158.273.343.350.261

Sponsors

Jessica Santos Passos Costa
Lead Sponsor
Universidade Estadual de Feira de Santana
Collaborator

Eligibility

Age
No minimum to 7 Days

Inclusion criteria

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

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).

Design outcomes

Primary

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

Secondary

MeasureTime frame
Describe the birth, socioeconomic and environmental variables of newborns 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 present in meconium and on the fifth day of life, through metagenomic DNA, of newborns 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 newborns) between groups

Countries

Brazil

Contacts

Public ContactGraciete;Jessica Vieira;Costa

Universidade Estadual de Feira de Santana;Universidade Estadual de Feira de Santana

gracieteovieira@gmail.com;jessy17_sp@hotmail.com+55 (075) 99977-5486;+55 (075) 98157-5484

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 6, 2026