NCT04685356: IBAIP

Effect of the IBAIP in Preterm Infants Neurodevelopment

Recruiting now NA Last updated 3 August 2025

What this trial tests

NA trial testing IBAIP : Infant Behaviour Assessment and Intervention Program in Premature Birth in 240 participants. Currently enrolling.

Timeline

8 November 2022

Primary endpoint
8 January 2028

8 January 2028

Quick facts

Lead sponsor	University Hospital, Brest
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	240
Start date	8 November 2022
Primary completion	8 January 2028
Estimated completion	8 January 2028
Sites	9 locations across France

Drugs / interventions tested

• 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)

Conditions studied

• Premature Birth — all drugs for Premature Birth →

Sponsor

University Hospital, Brest

Who can join

Adults 25 Weeks to 32 Weeks, any sex, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants.
   Orton J, Doyle LW, Tripathi T, Boyd R, et al · · 2024 · cited 37× · PMID 38348930 · DOI 10.1002/14651858.cd005495.pub5
2. Infant behavioural assessment and intervention program to support neurodevelopmental outcome of very preterm infants at two years corrected age: a cluster randomised controlled trial study protocol.
   Smith M, Kuhn P, Thiriez G, Debillon T, et al · · 2025 · PMID 40908020 · DOI 10.1136/bmjopen-2024-088167