Effect of the IBAIP in Preterm Infants Neurodevelopment

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Premature Birth

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04685356

29BRC17.0219

Details and patient eligibility

About

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.

Full 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 or home care) and continuing at home until the corrected age of 6 months. 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.

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

Enrollment: 240 estimated patients

Sex: All

Ages: 25 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

IBAIP Group

Experimental group

Description:

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).

Treatment:

Other: Bayley Scales of Infant and Toddler Development (BSID-IV)

Other: Parenting Stress Index (PSI)

Other: IBAIP : Infant Behaviour Assessment and Intervention Program

Other: Ages and Stages Questionnaire (ASQ)

Control group

Active Comparator group

Description:

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

Treatment:

Other: Bayley Scales of Infant and Toddler Development (BSID-IV)

Other: Parenting Stress Index (PSI)

Other: Ages and Stages Questionnaire (ASQ)

Other: Standard Support