Clinical trial NCT04685356: Effect of the IBAIP in Preterm Infants Neurodevelopment
Official title: Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 240
Sex: ALL
Minimum age (years): 25
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: This program consists of providing intervention, by a IBAIP trained and certified healthcare professional, with the child and his family, starting a few days before hospital discharge and continuing at home until the corrected age of 6 months. It focuses on the child's behaviors and consists of assisting the family in its interactions with the child so that these are adapted and responsive to the child's development needs over time through repeated interventions.

A cluster randomization will be used meaning the centers are randomized, not the individual patients. The centers will be randomized before the inclusion of patients in order to allow the physiotherapists or psychomotor therapists to be trained and certified to the IBAIP before the start of the trial.

Visit 1: Upon discharge from hospital, follow-up as part of standard care (control group) with at least 1 medical consultation per month during the first 6 months or according to the IBAIP program (experimental group) with one intervention in the week before discharge from hospital and at home after hospital discharge, with1 session once a month up to 6 months corrected age (i.e. 6 to 8 sessions) in addition to standard care.

Visit 2: At 6 months corrected age, parents' response to the PSI (Parenting Stress Index) questionnaire.

Visit 3: At two years corrected age :

* Assessment of the development quotient obtained on the BSID-III scale during a consultation with a neuro-psychologist.
* Parents' response to the PSI (Parenting Stress Index) questionnaire
* Parents' response to the ASQ (Ages and Stages Questionnaire

Eligibility 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 based on the Amiel-Tison neurological assessment

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 languageis not French
* Participation in another interventional study on the management of post-hospital neurodevelopment disorders

Primary outcomes:
measure: To assess the effect of the Infant Behavior Assessment and Intervention Program Program (IBAIP) in very preterm infants (< 33 weeks of gestation) on neurodevelopment at the corrected age of 2 years
timeFrame: 2 years of corrected age
Secondary outcomes:
measure: To assess the effect of IBAIP on the 5 sub-scores of BSID-III: cognitive, language, motor, socio-emotional and behavioral adaptive
timeFrame: 2 years of corrected age
measure: To assess the effect on the stress level of mothers and fathers
timeFrame: 2 years of corrected age
measure: Parental assessment of psychomotor development
timeFrame: 2 years of corrected age
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU Besançon
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: CHU Caen
city: Grenoble
country: France
facility: CHU Grenoble
city: Nantes
country: France
facility: CHU Nantes
city: Rennes
country: France
facility: CHU Rennes
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Tours
country: France
facility: CHU Tours
Study officials:
References: