Actively Recruiting

Phase Not Applicable
Age: 25Weeks - 32Weeks
All Genders
NCT04685356

Effect of the IBAIP in Preterm Infants Neurodevelopment

Led by University Hospital, Brest · Updated on 2025-08-03

240

Participants Needed

9

Research Sites

269 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Effect of the IBAIP in Preterm Infants Neurodevelopment

Who Can Participate

Age: 25Weeks - 32Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born between 25 weeks +0 days and 32 weeks +6 days of gestation, including multiples
  • Written informed consent from at least one parent or legal guardian, or both depending on family context
  • Normal neurological examination between 36 and 41 weeks of corrected age
Not Eligible

You will not qualify if you...

  • Intraventricular hemorrhage grade III or IV, or periventricular leukomalacia
  • Brain MRI abnormalities detected after 36 weeks of corrected age
  • Life-threatening medical conditions
  • Severe congenital abnormalities
  • Severe maternal physical or mental health conditions
  • Parents whose native language is not French
  • Participation in another interventional study on post-hospital neurodevelopment management

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

CHU Angers

Angers, France

Actively Recruiting

2

CHU Besançon

Besançon, France

Actively Recruiting

3

CHU Brest

Brest, France, 29200

Actively Recruiting

4

CHU Caen

Caen, France, 14033

Actively Recruiting

5

CHU Grenoble

Grenoble, France

Not Yet Recruiting

6

CHU Nantes

Nantes, France, 44000

Not Yet Recruiting

7

CHU Rennes

Rennes, France

Suspended

8

CHRU Strasbourg

Strasbourg, France

Actively Recruiting

9

CHU Tours

Tours, France, 37000

Actively Recruiting

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Research Team

J

Jean-Michel ROUE, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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