Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso

Launched by UNIVERSITY GHENT · Feb 6, 2023

Keywords

ClinConnect Summary

The DenBalo study is a clinical trial aimed at understanding why some newborns, called Small Vulnerable Newborns (SVNs), are at higher risk for health problems compared to healthy babies. Researchers will look at various biological factors, such as the gut bacteria, immune system, and breastmilk, to find out how these elements differ between SVNs and healthy newborns in urban Burkina Faso. The ultimate goal is to find ways to help prevent sickness and improve the chances of healthy pregnancies and births.

To be eligible for this study, mothers must be between 24 and 27 cm in fundal height (the distance from the pubic bone to the top of the uterus) and live in specific areas of Burkina Faso. They should also be pregnant with a single baby and agree to participate. Newborns who are considered SVNs may be born early, have low birth weight, or be small for their gestational age. Healthy controls will be matched based on certain criteria, such as being born after 37 weeks and weighing more than 2500 grams. Participants can expect to provide samples and data over the first six months of their baby's life, which will help researchers learn more about how to support the health of vulnerable newborns.

Gender

ALL

Eligibility 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