Effect of the IBAIP in Preterm Infants Neurodevelopment
NCT ID: NCT04685356
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2022-11-08
2028-01-08
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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IBAIP Group
Children 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).
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.
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-IV)
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.
Control group
Children 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
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-IV)
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.
Interventions
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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-IV)
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
25 Weeks
32 Weeks
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Jean-Michel ROUE
Role: primary
Role: backup
References
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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.
Other Identifiers
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29BRC17.0219
Identifier Type: -
Identifier Source: org_study_id
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