Study on gut bacteria and brain development in premature infants
Gut Bacteria and Brain of the Baby: to Link up the Dynamic of Gut Colonization in Preterms Born at Gestational Age of 30-326/7 Weeks and Their Psychomotor Development at 2 Years
This study looks at how gut bacteria and feeding habits affect brain development in premature babies over their first two years of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 30 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 1 site (Rennes) |
| Trial ID | NCT04432636 on ClinicalTrials.gov |
What this trial studies
This study follows a cohort of 100 moderate preterm infants born between 30 and 36 weeks of gestation at Rennes Hospital. The infants will be monitored for up to two years to assess the relationship between gut bacteria and brain development. Data will be collected on environmental factors, maternal and infant feces, and infant feeding behaviors during the first ten months of life. The goal is to understand how these factors influence the health and development of preterm infants.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born at 30-36 weeks of gestation who are admitted to the neonatal intensive care unit at Rennes Hospital.
Not a fit: Patients with genetic diseases or digestive defects will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and interventions for the health and development of premature infants.
How similar studies have performed: While studies on gut microbiota and infant health are ongoing, this specific approach focusing on moderate preterm infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterms born at gestational age of 30-326/7 weeks of amenorrhea * Preterms born in Rennes hospital or preterms born in another hospital but moved to Rennes hospital during the first 24 h of postnatal life * Parents or holder of the parental authority who give in writing their free, prior and informed consent for recruitment of their baby who has a social security system * Mother of the baby who gives in writing her free, prior and informed consent to be involved in the present study * Mother of the baby who has a social security system Exclusion Criteria: * Preterms born with a genetic disease * Preterms born with a digestive defect * Uncompetent parents under the protection of guardianship or tutelage services
Where this trial is running
Rennes
- CHU Rennes - Hôpital Sud — Rennes, France (Recruiting)
Study contacts
- Study coordinator: Amandine BELLANGER
- Email: amandine.bellanger@chu-rennes.fr
- Phone: 02 99 23 48 21
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.