Effect of the IBAIP in Preterm Infants Neurodevelopment
IBAIP
Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age
1 other identifier
interventional
240
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
December 28, 2020
CompletedStudy Start
First participant enrolled
November 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 8, 2028
August 3, 2025
July 1, 2025
5.2 years
December 22, 2020
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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-IV) 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 Outcomes (3)
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
To assess the effect on the stress level of mothers and fathers
2 years of corrected age
Parental assessment of psychomotor development
2 years of corrected age
Study Arms (2)
IBAIP Group
EXPERIMENTALChildren 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).
Control group
ACTIVE COMPARATORChildren 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
Interventions
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.
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
Index used to detect difficulties sufficiently significant that they might require psychosocial intervention
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
CHU Angers
Angers, France
CHU Besançon
Besançon, France
CHU Brest
Brest, 29200, France
CHU Caen
Caen, 14033, France
CHU Grenoble
Grenoble, France
CHU Nantes
Nantes, 44000, France
CHU Rennes
Rennes, France
CHRU Strasbourg
Strasbourg, France
CHU Tours
Tours, 37000, France
Related Publications (1)
Smith M, Kuhn P, Thiriez G, Debillon T, Datin-Dorriere V, Leboucher B, Mitanchez D, Courtois-Communier E, Sizun J, Roue JM. Infant behavioural assessment and intervention program to support neurodevelopmental outcome of very preterm infants at two years corrected age: a cluster randomised controlled trial study protocol. BMJ Open. 2025 Sep 4;15(9):e088167. doi: 10.1136/bmjopen-2024-088167.
PMID: 40908020DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2020
First Posted
December 28, 2020
Study Start
November 8, 2022
Primary Completion (Estimated)
January 8, 2028
Study Completion (Estimated)
January 8, 2028
Last Updated
August 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning three years and ending fifteen years following the final study report completion
- Access Criteria
- Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
All collected data that underlie results in a publication