Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-01-01 @ 3:37 PM
Study NCT ID:
NCT04685356
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the IBAIP in Preterm Infants Neurodevelopment
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IBAIP
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: