Effect of the IBAIP in Preterm Infants Neurodevelopment

Not Applicable

Recruiting

• Conditions: Premature Birth

• Registration Number: NCT04685356
• Lead Sponsor: University Hospital, Brest

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 hospitalization discharge (hospital or home care) 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 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-IV scale during a consultation with a neuro-psychologist or pediatrician.

* Parents' response to the PSI (Parenting Stress Index) questionnaire

* Parents' response to the ASQ (Ages and Stages Questionnaire

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2022-11-08
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-03
• Primary Completion: 2028-01-08
• Study Completion: 2028-01-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	2 years of corrected age	Patient neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development (BSID-IV) scale. This test studies the different notions of development: cognitive, language, motor skills, socio-emotional, behavioral, communication and autonomy.

Secondary Outcome Measures

Name	Time	Method
To assess the effect of IBAIP on the 5 sub-scores of BSID-IV: cognitive, language, motor, socio-emotional and behavioral adaptive	2 years of corrected age	The BSID-IV scale can be analyzed at the level of each of these subscales. The different scores obtained allow us to identify precisely at what level the effect on neurodevelopment was the most significant.
To assess the effect on the stress level of mothers and fathers	2 years of corrected age	To assess through the response to the Parental Stress Index. This questionnaire consists in 120 items using a 5-level Likert scale. It allows the assessment of life stress score, parental stress and child stress.
Parental assessment of psychomotor development	2 years of corrected age	Ages and Stages questionnaire completed by the parents to assess the child's neurodevelopment in 5 areas (fine motor skills, gross motor skills, communication, problem solving, individual or social skills).

Trial Locations

Locations (9)

CHU Angers; 🇫🇷 Angers, France

CHU Besançon; 🇫🇷 Besançon, France

CHU Brest; 🇫🇷 Brest, France

CHU Caen; 🇫🇷 Caen, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Rennes; 🇫🇷 Rennes, France

CHRU Strasbourg; 🇫🇷 Strasbourg, France

CHU Tours; 🇫🇷 Tours, France