Intervention program for neurodevelopment in preterm infants
Official title: Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age
Run by University Hospital, Brest · NCT04685356 · Data updated 2026-11-12
This study is testing a program that helps very preterm infants develop better by providing early support and guidance to their families from trained professionals.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 25 Weeks to 32 Weeks |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 9 sites (Angers and 8 other locations) |
| Status | Recruiting |
| Started | November 8, 2022 |
| Main results expected | January 8, 2028 |
| Study ends | January 8, 2028 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT04685356 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are preterm infants born between 25 weeks and 32 weeks and 6 days of gestation who have a normal neurological examination.
✕Probably not a fit
Patients with severe neurological conditions, significant congenital abnormalities, or those participating in other interventional studies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This program aims to improve neurodevelopmental outcomes in very preterm infants by providing early interventions through the Infant Behaviour Assessment and Intervention Program (IBAIP). The intervention is conducted by trained healthcare professionals starting a few days before hospital discharge and continues at home until the infant reaches six months corrected age. The approach focuses on enhancing family interactions with the child to meet developmental needs through regular sessions. The study employs a cluster randomization method, where centers are randomized to either the intervention or control group before patient inclusion.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the neurodevelopmental outcomes of very preterm infants, potentially reducing long-term developmental disorders.
How similar studies have gone: Other studies have shown success with early intervention approaches for preterm infants, suggesting that this method could be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria : * Preterm infants born (including multiple pregnancies) at a gestational age between 25 weeks +0 days and 32 weeks + 6days. * Written informed consent of at least one of the parents / legal guardian or 2 parents / legal guardians depending on the family context * Normal neurological examination between 36 and 41 weeks of corrected age Exclusion Criteria: * Intraventricular hemorrhage (III or IV), periventricular leukomalacia * Brain MRI abnormalities performed after 36 weeks of corrected age * Life-threatening pathology * Severe congenital abnomality * Severe maternal pathology (physical and / or mental) * Parents whose native language is not French * Participation in another interventional study on the management of post-hospital neurodevelopment disorders
Where it's running
-
CHU Angers
Angers, France Recruiting -
CHU Besançon
Besançon, France Recruiting -
CHU Brest
Brest, France Recruiting -
CHU Caen
Caen, France Recruiting -
CHU Grenoble
Grenoble, France Recruiting -
CHRU Strasbourg
Strasbourg, France Recruiting
Show 3 more locations
-
CHU Tours
Tours, France Recruiting -
CHU Nantes
Nantes, France Withdrawn -
CHU Rennes
Rennes, France Withdrawn
Study contacts
- Study coordinator: Jean-Michel ROUE, PhD
- Email: jean-michel.roue@chu-brest.fr
- Phone: 2.98.22.36.67
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.