Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators

Premature Birth Clinical Trial

Official title: Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators

Status Completed

Clinical Trial Summary

This study is to extend our previous research to longitudinally examine the effectiveness of intervention programs (FCIP and UCP) for VLBW preterm children in Taiwan at seven years of age. Gender and maternal education level matched term children will also be included to serve as the reference group for comparison of developmental outcomes. The intervention had been delivered from birth to one year of corrected age in the previous study. Effectiveness examined will include child and parent outcomes. Primary outcome refers to measures of child neurobehavioral and neurophysiological functions. Neurobehavioral assessment includes cognitive, motor and behavioral measurement. Neurophysiological assessment refers to electroencephalogram/event-related potential examination and cognition/motor dual tasks that will be used to investigate the neurological pathways underlying the effective intervention. Secondary outcomes refer to child growth and health, and the quality of parenting measures.

Clinical Trial Description

Preterm children present more cognitive impairments, psychological and behavioral problems, motor and coordination impairments than their term counterparts. These impairments may cause the difficulties of learning and adaptation at the school age when facing multiple and complicate environmental stimulations in preterm children. Accumulating data on early intervention for preterm infants in Eastern and Western countries have demonstrated short- to medium-term benefits on enhancing child neurodevelopment outcomes. However, rare studies have examined the effectiveness of early intervention for preterm infants and its underlying neural mechanism. To meet the contemporary concept of family centered care, we have developed a family-centered intervention program (FCIP) for preterm infants with very low birth weight (VLBW, birth weight <1,500 g) in Taiwan and have found short-term developmental benefit with respect to a usual care program (UCP) via a multi-centered, randomized controlled trial. Therefore, this three-year project is aimed to continuously follow-up the effectiveness of FCIP on child and parent outcomes in VLBW preterm infants at school age. A total of 275 VLBW preterm children (269 participants and 6 pilots) who had participated in our previous randomized controlled study and 45 term children will be assessed growth, health, neurobehavioral functions (cognition, language, motor and behaviors), electroencephalography and event-related potentials (in the resting state, cognitive inhibitory control and working memory procedures) and cognition/motor dual tasks at 7 years of age. Parents will be assessed for stress using the Parenting Stress Index/Long Form and quality of life with the World Health Organization Quality of Life- Brief Taiwan Version. The effect of early intervention for preterm children from the neonatal period to school age will provide important information to help medical professionals and public policy makers design effective intervention for Taiwanese preterm children. The continuous neurophysiological and neurobehavioral data are crucial for understanding the neurophysiological mechanisms underlying neurobehavioral changes following intervention. ;

Related Conditions & MeSH terms

• Premature Birth

• NCT number: NCT03668626
• Study type: Interventional
• Source: National Taiwan University Hospital
• Status: Completed
• Phase: N/A
• Start date: October 17, 2018
• Completion date: December 31, 2021