Effect of the IBAIP in Preterm Infants Neurodevelopment

Premature Birth Clinical Trial

— IBAIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04685356
• Other study ID #: 29BRC17.0219
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: January 8, 2028

Study information

• Verified date: April 2024
• Source: University Hospital, Brest
• Contact: Jean-Michel ROUE, PhD
• Phone: 2.98.22.36.67
• Email: jean-michel.roue[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 8, 2028
• Est. primary completion date: January 8, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• IBAIP : Infant Behaviour Assessment and Intervention Program
The IBAIP intervention program consists of providing an intervention with the child and their family, at home, upon discharge from hospital and up to a corrected age of 6 months. Interventions therefore take place at the early stage of the child's brain development. The intervention is performed by a IBAIP-trained and certified physiotherapist or psychomotor therapist trained , at the rate of one session per month over a period of approximately 6 to 8 months (6 months of corrected age). The session takes place in the child's usual living environment, at home, in the presence of at least one of the parents. 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.
• Standard Support
One medical consultation per month and, if indicated by the physician providing follow-up, medical specialist and / or paramedical (physiotherapy, speech therapy, psychomotricity, etc.) consultations including interventions in the case of developmental delays
• Ages and Stages Questionnaire (ASQ)
Global development screening tool
• Parenting Stress Index (PSI)
Index used to detect difficulties sufficiently significant that they might require psychosocial intervention
• Bayley Scales of Infant and Toddler Development (BSID-III)
This test was designed to measure the development of infants / young children. This assessment examines all spheres of child development, identifies children with developmental delay and assesses children's developmental performance compared to their peers.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development (BSID-III) scale. This test studies the different notions of development: cognitive, language, motor skills, socio-emotional, behavioral, communication and autonomy.	2 years of corrected age
Secondary	To assess the effect of IBAIP on the 5 sub-scores of BSID-III: cognitive, language, motor, socio-emotional and behavioral adaptive	The BSID-III 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.	2 years of corrected age
Secondary	To assess the effect on the stress level of mothers and fathers	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.	2 years of corrected age
Secondary	Parental assessment of psychomotor development	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).	2 years of corrected age