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Effect of the IBAIP in Preterm Infants Neurodevelopment

RecruitingNAAges 25 Weeks - 32 WeeksAllUniversity Hospital, Brest
NCT04685356 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 dev

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📋 Eligibility rules (as published)
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 language is not French * Participation in another interventional study on the management of post-hospital neurodevelopment disorders
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What it tests

  • IBAIP : Infant Behaviour Assessment and Intervention Program
  • Standard Support
  • Ages and Stages Questionnaire (ASQ)
  • Parenting Stress Index (PSI)
  • Bayley Scales of Infant and Toddler Development (BSID-IV)
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Where

9 sites
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

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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