Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04685356

Effect of the IBAIP in Preterm Infants Neurodevelopment

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

25 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBAIP : Infant Behaviour Assessment and Intervention Program

Other

The IBAIP intervention program consists of providing an intervention with the child and their family, at home, upon discharge from hospital and up to a corrected age of 6 months. Interventions therefore take place at the early stage of the child's brain development. The intervention is performed by a IBAIP-trained and certified physiotherapist or psychomotor therapist trained , at the rate of one session per month over a period of approximately 6 to 8 months (6 months of corrected age). The session takes place in the child's usual living environment, at home, in the presence of at least one of the parents. 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.

Standard Support

Other

One medical consultation per month and, if indicated by the physician providing follow-up, medical specialist and / or paramedical (physiotherapy, speech therapy, psychomotricity, etc.) consultations including interventions in the case of developmental delays

Ages and Stages Questionnaire (ASQ)

Other

Global development screening tool

Parenting Stress Index (PSI)

Other

Index used to detect difficulties sufficiently significant that they might require psychosocial intervention

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

Other

This test was designed to measure the development of infants / young children. This assessment examines all spheres of child development, identifies children with developmental delay and assesses children's developmental performance compared to their peers.

Primary outcomes

  1. To assess the effect of the Infant Behavior Assessment and Intervention Program Program (IBAIP) in very preterm infants (< 33 weeks of gestation) on neurodevelopment at the corrected age of 2 years

    Time frame: 2 years of corrected age

    Patient neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development (BSID-IV) scale. This test studies the different notions of development: cognitive, language, motor skills, socio-emotional, behavioral, communication and autonomy.

Secondary outcomes

  1. To assess the effect of IBAIP on the 5 sub-scores of BSID-IV: cognitive, language, motor, socio-emotional and behavioral adaptive

    Time frame: 2 years of corrected age

    The BSID-IV scale can be analyzed at the level of each of these subscales. The different scores obtained allow us to identify precisely at what level the effect on neurodevelopment was the most significant.

  2. To assess the effect on the stress level of mothers and fathers

    Time frame: 2 years of corrected age

    To assess through the response to the Parental Stress Index. This questionnaire consists in 120 items using a 5-level Likert scale. It allows the assessment of life stress score, parental stress and child stress.

  3. Parental assessment of psychomotor development

    Time frame: 2 years of corrected age

    Ages and Stages questionnaire completed by the parents to assess the child's neurodevelopment in 5 areas (fine motor skills, gross motor skills, communication, problem solving, individual or social skills).

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Michel ROUE, PhD

CONTACT

[email protected]

2.98.22.36.67 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age

Acronym: IBAIP

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Dec 28, 2020
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.