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Updated: Sep 9, 2025
Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Infant behavioural assessment and intervention program to support neurodevelopmental outcome of very preterm infants
Meghan Smith1, Pierre Kuhn2,3, Gerard Thiriez4
1Departement of Neonatal Medicine and Pediatric Critical Care Medecine, Brest University Hospital Centre, Brest, Bretagne, France.
Insights
This study investigates the Infant Behavioral Assessment and Intervention Program (IBAIP) for preterm infants. The goal is to improve cognitive development and motor skills in infants born before 33 weeks gestational age.
Area of Science:
- Neonatal care
- Developmental pediatrics
- Clinical trials
Background:
- Preterm infants, particularly those born before 33 weeks gestational age, face significant risks of developmental impairment.
- Early interventions have demonstrated positive effects on medical outcomes, cognitive development, and parental anxiety in preterm infants.
- The Infant Behavioral Assessment and Intervention Program (IBAIP) has shown promise in enhancing cognitive and motor development in a Dutch cohort.
Purpose of the Study:
- To confirm the positive effects of the Infant Behavioral Assessment and Intervention Program (IBAIP) on cognitive and motor development in preterm infants within a French multicentric setting.
- To evaluate the efficacy of IBAIP through a cluster randomized controlled trial.
- To assess the impact of IBAIP on secondary outcomes including subscores, developmental milestones, and parental stress.
Main Methods:
- A multicentric, cluster randomized controlled trial involving eight French neonatal intensive care units (NICUs).
- Inclusion of 240 infants born between 25 and 33 weeks gestational age.
- Intervention group receives monthly home visits from hospital discharge until 6 months corrected age, alongside standard care; control group receives standard care.
- Primary endpoint: composite cognitive score at 2 years corrected age (Bayley Scale of Infant Development Fourth Edition - BSID IV).
- Secondary endpoints: BSID IV subscores, Ages and Stages Questionnaire scores, and parental stress.
- Intention-to-treat analysis with univariate and multivariate analyses.
Main Results:
- This section is to be filled once the study results are available. The abstract describes the methodology and planned analysis, not the findings.
Conclusions:
- This study aims to provide robust evidence on the effectiveness of the Infant Behavioral Assessment and Intervention Program (IBAIP) in a French population.
- If proven effective, IBAIP could be considered for nationwide implementation to support preterm infant development.
- The findings will contribute to optimizing developmental support strategies for high-risk infants.
Introduction:
Preterm infants are at risk of developmental impairment, especially those born before 33 weeks gestational age. Many studies have shown a positive impact of early interventions on medical outcomes during hospitalisation, long-term cognitive development and parental anxiety. Infant Behavioral Assessment and Intervention Program (IBAIP) has shown positive effects on cognitive development but also on motor impairment in a Dutch cohort. We aim to confirm these results in a multicentric, cluster randomised controlled trial in a French setting.
Methods And Analysis:
Eight French neonatal intensive care units (NICUs) will be randomised before study initiation to intervention or control group. We aim to include 240 infants born between 25 weeks and 33 weeks gestational age. IBAIP intervention comprises monthly home visits with a trained professional from hospital discharge until 6 months corrected age. Both groups receive standard care according to local organisation. The primary endpoint is composite cognitive score at 2 years corrected age using Bayley Scale of Infant Development Fourth Edition (BSID IV). Secondary endpoints include BSID IV subscores, Ages and Stages Questionnaire scores and parental stress. Analysis is in intention to treat. Univariate and multivariate analysis will be performed on primary and secondary endpoints.
Ethics And Dissemination:
Informed consent from one or both parents will be necessary for all patients. Study results will be published in peer-reviewed scientific journals. If our hypothesis is confirmed, IBAIP could be implemented on a nationwide scale. The study was registered with clinicaltrials.gov (ID: 29BRC17.0219).
Trial Registration Number:
NCT04685356.
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