Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Health… (NCT05730569) | Clinical Trial Compass
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Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso
Burkina Faso140 participantsStarted 2023-01-09
Plain-language 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.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 vis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differential abundances of bacterial genera in the infant gut microbiota
Timeframe: to be assessed at on days 3, 7, 14, 30, 60, 180 of life