Study of the Infant Behavioral Assessment and Intervention Program IBAIP at Home for Preterm Infants Born Between 25 and 32 Weeks to Support Development Through 2 Years Corrected Age
Led by University Hospital, Brest · Updated on 2026-06-26
240
Participants Needed
9
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the effects of the Infant Behavioral Assessment and Intervention Program IBAIP on neurodevelopment in very preterm infants born before 33 weeks of gestation. These infants are more likely to experience neuromotor, behavioral, and cognitive development disorders compared to full-term infants. The study focuses on early interventions during hospitalization or after discharge to support developmental functions and improve parent-infant interactions.
The IBAIP intervention is delivered by trained and certified healthcare professionals starting shortly before hospital discharge and continuing at home until the infant reaches 6 months corrected age. Sessions occur once a month at home with the parents present, aiming to tailor interactions to the childs developmental needs. Participants are assigned by center to either receive this IBAIP intervention plus standard care or standard care alone, which includes regular medical consultations and specialist follow-up as needed.
Participants will be involved in monthly sessions or medical consultations during the first 6 months after discharge, with follow-up assessments at 6 months and 2 years corrected age. These include developmental evaluations using the Bayley Scales BSID-IV, parental stress questionnaires PSI, and the Ages and Stages Questionnaire ASQ. The study will measure neurodevelopment outcomes at 2 years corrected age, parental stress levels, and psychomotor development, with ongoing monitoring throughout the study duration.
CONDITIONS
Brief Title
Effect of the IBAIP in Preterm Infants Neurodevelopment
Research Team
J
Jean-Michel ROUE, PhD
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Preterm infants born between 25 weeks +0 days and 32 weeks +6 days of gestation
Written informed consent from at least one parent or legal guardian
Normal neurological examination between 36 and 41 weeks corrected age
You will not qualify if you...
Intraventricular hemorrhage grade III or IV, or periventricular leukomalacia
Brain MRI abnormalities performed after 36 weeks corrected age
Life-threatening pathology
Severe congenital abnormality
Severe maternal physical or mental pathology
Parents whose native language is not French
Participation in another interventional study on post-hospital neurodevelopment disorders
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Intervention
Duration - Up to 6 months corrected age
Participants receive either the IBAIP intervention at home with monthly sessions led by a trained therapist plus standard care, or standard care alone with monthly medical consultations and specialist follow-up as needed.
Monthly sessions or medical consultations
Follow-up Assessments
Duration - Up to 2 years corrected age
Participants undergo developmental assessments and questionnaires at 6 months and 2 years corrected age to evaluate neurodevelopment, parental stress, and psychomotor development.
2 visits (6 months and 2 years corrected age)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Premature - Weight 1000g-2499g or Gestation of 28-37weeks
Actively Recruiting
1 location
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Published Research Related To This Trial
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.