Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso
Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso (DenBalo): Gut Microbiota, Immune System, and Breastmilk Assembly and Development in the First Days and Weeks of Life
University Ghent
140 participants
Jan 9, 2023
OBSERVATIONAL
Conditions
Summary
The aim of the DenBalo study is to apply integrated multi-omics methods to examine the biological mechanisms underlying this vulnerability in Small Vulnerable Newborns (SVNs) in LMICs, with the ultimate goal of identifying targeted interventions to reduce morbidity and mortality in this high-risk population. The evidence generated from this project will ultimately help promote healthy pregnancies and the birth of healthy babies. To achieve this goal, three research objectives are proposed: 1. To describe and compare gut microbiota, immune system and breastmilk components in SVNs versus healthy community controls in urban Burkina Faso. 2. To describe and compare the development of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso. 3. To investigate the relationship between the composition of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso.
Eligibility
Inclusion Criteria19
- Fundal height between 24 and 27 cm
- Woman living in the health zone of Accart-Ville, Colma 1 or Farakan
- Woman not planning to give birth or move outside the study area in the first 6 months of the infant's life
- Gestational age between 24 weeks 0 completed day and 29 weeks 6 days (ultrasound)
- Monofetal pregnancy without visible malformation
- Woman agreeing to give her informed consent to participate in the study
- Delivery of a live birth
- Vaginal birth
- Absence of severe infectious pathology, severe pneumopathy or respiratory distress in the neonate
- Neonates who did not receive corticosteroids or antibiotics at birth
- For Small Vulnerable Newborns (SVNs):
- Low birth weight: <2500g; and/or,
- Preterm: born between the 34th and 37th week of pregnancy; and/or,
- Small for Gestational Age: <10 percentile of INTERGROWTH-21st birthweight standards.
- For healthy community controls:
- Neonate born after the 37th week of pregnancy; and,
- Birth weight >2500g; and,
- ≥10 percentile of INTERGROWTH-21st birthweight standards; and,
- Possible match with a SVN neonate already recruited into the study.
Exclusion Criteria9
- Fundal height <24 cm or >27 cm
- Woman living outside the sanitary zone of the Accart-Ville, Colma 1 or Farakan
- Woman planning to give birth outside the study area or to move from it within the first 6 months of the infants's life
- Gestational age <24 weeks or ≥30 weeks (ultrasound)
- Multi-fetal pregnancy
- Malformation visible on ultrasound
- Cesarean delivery
- Neonate with severe infectious disease, severe pneumopathy or respiratory distress
- Neonate who received corticosteroids or antibiotics just after birth
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05730569