Comparing biological vulnerability in small vulnerable newborns and healthy controls in 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
This study is trying to understand the biological differences between small vulnerable newborns and healthy babies in Burkina Faso to see how these factors affect their growth and health in the first six months of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University Ghent Academic / other |
| Locations | 1 site (Bobo-Dioulasso) |
| Trial ID | NCT05730569 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the biological mechanisms that contribute to the vulnerability of Small Vulnerable Newborns (SVNs) in urban Burkina Faso by utilizing integrated multi-omics methods. It will compare gut microbiota, immune system development, and breastmilk components between SVNs and healthy community controls. The study will also track these biological factors during the first six months of life to understand their relationship with growth and development. Ultimately, the findings aim to inform targeted interventions to reduce morbidity and mortality in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates include pregnant women in urban Burkina Faso with gestational ages between 24 and 29 weeks, planning to deliver a live, vaginal birth.
Not a fit: Patients who are not pregnant or those with severe infectious pathology or malformations in the neonate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes for vulnerable newborns through targeted interventions.
How similar studies have performed: While similar studies have explored aspects of neonatal health, this specific multi-omics approach in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * 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 CRITERIA * 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
Where this trial is running
Bobo-Dioulasso
- Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté) — Bobo-Dioulasso, Burkina Faso (Recruiting)
Study contacts
- Principal investigator: Trenton Dailey-Chwalibóg, MPH, PhD — University Ghent
- Study coordinator: Trenton Dailey-Chwalibóg, MPH, PhD
- Email: Trenton@Dailey-Chwalibog.com
- Phone: +33603233614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.