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

NCT03668626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2022-09-22

No results posted yet for this study

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.

Conditions

  • Premature Birth

Interventions

OTHER

Family-centered intervention program (FCIP)

This program included in-hospital intervention, after-discharge intervention and neonatal follow-up. Five sessions of in-hospital intervention emphasized modulation of the NICU, teaching of child developmental skills, feeding support, massage, interactional activities and parent support and education. The 7-session after-discharge intervention consisted of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education.

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Suh-Fang Jeng, Professor · School and Graduate Institute of Physical Therapy, National Taiwan University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2021-07-31
Completion
2021-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03668626 on ClinicalTrials.gov