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

NCT03668626 | Completed

• 1 other identifier: 201801017RINA
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intervention; effectiveness

Outcome Measures

Primary Outcomes (1)

• Child: Neurodevelopment- The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition

  The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (WPPSIR-IV) measures cognitive development of children aged from 6 years to 16 years and 11 months old. The test structure of WPPSIR-IV includes 14 subscales and several levels of interpretation: verbal comprehension index, perceptual reasoning index, working memory index, processing speed index and full scale intelligence quotient. The scaled score of each subscale ranges from 1 to 19. The total scaled score is the sum of the subscale scores ranging from 10 to 190. The full scale intelligence quotient will be converted from the total scaled score with a higher value indicating a better performance.

  2 years

Secondary Outcomes (12)

• Child: Past medical history

  up to 2 years

• Child: Academic performance

  up to 2 years

• Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition

  2 years

• Child: Electroencephalogram (EEG)

  2 years

• Child: Event-related potential (ERP)

  2 years

Study Arms (3)

Term infants

NO INTERVENTION

Healthy term infants

Usual care program (UCP)

NO INTERVENTION

In-hospital and after-discharge intervention (telephone calls)

Family-centered intervention program (FCIP)

EXPERIMENTAL

In-hospital and after-discharge intervention (clinic and home visits)

Other: Family-centered intervention program (FCIP)

Interventions

Family-centered intervention program (FCIP) OTHER

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.

Also known as: early intervention program

Family-centered intervention program (FCIP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• birth body weight \< 1500 grams
• gestational age \< 37 weeks
• parents of Taiwan nationality, married or together at delivery, and northern family residing in greater Taipei and southern family residing in greater Tainan, Kaohsiung, or Chiayi
• birth body weight \> 2000 grams
• gestational age \> 37 weeks
• parents of Taiwan nationality

You may not qualify if:

• severe neonatal and perinatal diseases (e.g., seizures, hydrocephalus, meningitis, grade III-IV IVH and grade II NEC)
• congenital or chromosome abnormality
• mother \< 18 years, with mental retardation or history of maternal substance abuse at any time (smoking, alcohol and drug)
• Terminated Criteria for Preterm infants:
• diagnosis of brain injury (e.g., PVL, stage IV ROP or greater)
• severe cardiopulmonary disease requiring invasive or non-invasive ventilator use at hospital discharge
• hospital discharge beyond 44 weeks' post-menstrual age.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Suh-Fang Jeng, Professor

  School and Graduate Institute of Physical Therapy, National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 12, 2018
• Study Start: October 17, 2018
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)