Actively Recruiting
Led by University Hospital, Brest · Updated on 2025-08-03
240
Participants Needed
9
Research Sites
N/A
Total Duration
Researchers are evaluating the Infant Behavior Assessment and Intervention Program (IBAIP) to support the neurodevelopment of very preterm infants born before 33 weeks of gestation. These infants often face higher risks of neuromotor, behavioral, and cognitive development disorders compared to full-term infants. The study aims to assess whether early family-centered interventions starting just before hospital discharge can improve developmental outcomes by focusing on infant self-regulation and parent-child interactions. The trial compares two groups: one receiving the IBAIP intervention and another receiving standard medical follow-up care. The IBAIP group receives monthly home visits by trained healthcare professionals from discharge until 6 months corrected age, focusing on supporting parent-infant interactions. The control group receives routine monthly medical consultations and additional specialist referrals if needed. Evaluations include developmental and stress assessments at 6 months and 2 years corrected age. Participants will undergo assessments including the Bayley Scales of Infant and Toddler Development (BSID-IV), Parenting Stress Index (PSI), and Ages and Stages Questionnaire (ASQ). Follow-up includes medical consultations and parental questionnaires to measure infant development and parental stress. The primary outcome is neurodevelopment at 2 years corrected age. The study includes detailed monitoring of developmental progress and parental response over this period, with participation lasting until the child reaches 2 years corrected age.
CONDITIONS
Effect of the IBAIP in Preterm Infants Neurodevelopment
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive the Infant Behavioral Assessment and Intervention Program (IBAIP) consisting of one session per month at home with a trained professional, starting a few days before hospital discharge and continuing until 6 months corrected age. This focuses on assisting the family in interactions adapted to the child's developmental needs. Participants also receive standard medical follow-up.
1 session per month at home, 6 to 8 sessions in total
Duration - From 6 months to 2 years corrected age
Participants undergo assessments at 6 months and 2 years corrected age, including questionnaires on parenting stress and developmental screenings and evaluations by neuropsychologists or pediatricians.
1 visit at 6 months and 1 visit at 2 years (in-person)
Total: 9 locations
1
CHU Angers
Angers, France
Actively Recruiting
2
CHU Besançon
Besançon, France
Actively Recruiting
3
CHU Brest
Brest, France, 29200
Actively Recruiting
4
CHU Caen
Caen, France, 14033
Actively Recruiting
5
CHU Grenoble
Grenoble, France
Not Yet Recruiting
6
CHU Nantes
Nantes, France, 44000
Not Yet Recruiting
7
CHU Rennes
Rennes, France
Suspended
8
CHRU Strasbourg
Strasbourg, France
Actively Recruiting
9
CHU Tours
Tours, France, 37000
Actively Recruiting
J
Jean-Michel ROUE, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Meghan Smith, Pierre Kuhn, Gerard Thiriez...
https://pubmed.ncbi.nlm.nih.gov/40908020