Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 7 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU Besançon
RECRUITING
Besançon
CHU Brest
RECRUITING
Brest
CHU Caen
RECRUITING
Caen
CHU Grenoble
NOT_YET_RECRUITING
Grenoble
CHU Nantes
NOT_YET_RECRUITING
Nantes
CHU Rennes
SUSPENDED
Rennes
CHRU Strasbourg
RECRUITING
Strasbourg
CHU Tours
RECRUITING
Tours
Contact Information
Primary
Jean-Michel ROUE, PhD
jean-michel.roue@chu-brest.fr
2.98.22.36.67
Time Frame
Start Date: 2022-11-08
Estimated Completion Date: 2028-01-08
Participants
Target number of participants: 240
Treatments
Experimental: IBAIP Group
Children benefiting from assessment and intervention providing by a healthcare professional (physiotherapist or psychomotor therapist) trained and certified for IBAIP. This care will take place upon discharge from the hospital at the rate of one session per month for 6 months. The sessions will take place in the presence of at least one of the parents and at home. These children will also benefit from standard follow-up (medical follow-up, paramedical or specialized medical support depending on the development and needs).
Active_comparator: Control group
Children benefiting from standard care upon discharge from hospital with 1 medical consultation per month and, medical sepcialist and / or paramedical(physiotherapy, speech therapy, psychomotricity, etc.). consultations if indicated by the physician providing follow-up
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov