Status:
RECRUITING
Effect of the IBAIP in Preterm Infants Neurodevelopment
Lead Sponsor:
University Hospital, Brest
Conditions:
Premature Birth
Eligibility:
All Genders
25-32 years
Phase:
NA
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 bef...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
November 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 8 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04685356
Start Date
November 8 2022
End Date
January 8 2028
Last Update
August 3 2025
Active Locations (9)
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1
CHU Angers
Angers, France
2
CHU Besançon
Besançon, France
3
CHU Brest
Brest, France, 29200
4
CHU Caen
Caen, France, 14033