Actively Recruiting
Effect of the IBAIP in Preterm Infants Neurodevelopment
Led by University Hospital, Brest · Updated on 2025-08-03
240
Participants Needed
9
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants. These neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation. Post-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered. Early interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life. The IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.
CONDITIONS
Official Title
Effect of the IBAIP in Preterm Infants Neurodevelopment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants born between 25 weeks +0 days and 32 weeks +6 days of gestation, including multiples
- Written informed consent from at least one parent or legal guardian, or both depending on family context
- Normal neurological examination between 36 and 41 weeks of corrected age
You will not qualify if you...
- Intraventricular hemorrhage grade III or IV, or periventricular leukomalacia
- Brain MRI abnormalities detected after 36 weeks of corrected age
- Life-threatening medical conditions
- Severe congenital abnormalities
- Severe maternal physical or mental health conditions
- Parents whose native language is not French
- Participation in another interventional study on post-hospital neurodevelopment management
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
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
Research Team
J
Jean-Michel ROUE, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
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