Effect of the IBAIP in Preterm Infants Neurodevelopment

Recruiting now · Not applicable

Conditions studied: Premature Birth

In brief

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.

Key facts

Study ID

NCT04685356

Run by

University Hospital, Brest

People needed

240

Starts

2022-11-08

Expected to finish

2028-01-08

Last updated by the study team

2026-06-26

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• CHU Tours — Tours, France (enrolling)
• CHU Besançon — Besançon, France (enrolling)
• CHU Brest — Brest, France (enrolling)
• CHU Caen — Caen, France (enrolling)
• CHU Grenoble — Grenoble, France (enrolling)
• CHRU Strasbourg — Strasbourg, France (enrolling)
• CHU Angers — Angers, France (enrolling)
• CHU Nantes — Nantes, France
• CHU Rennes — Rennes, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.