Effect of the IBAIP in Preterm Infants Neurodevelopment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-32
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Intraventricular hemorrhage (III or IV), periventricular leukomalacia

Brain MRI abnormalities performed after 36 weeks of corrected age

Life-threatening pathology

Severe congenital abnomality

Trial design

Treatments tested in this trial

  • 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)

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators