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

NCT ID: NCT03668626

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2021-12-31

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.

Detailed 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.

Conditions

Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Term infants

Healthy term infants

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usual care program (UCP)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Family-centered intervention program (FCIP)

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

Group Type: EXPERIMENTAL

Family-centered intervention program (FCIP)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

early intervention program

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suh-Fang Jeng, Professor

Role: PRINCIPAL_INVESTIGATOR

School and Graduate Institute of Physical Therapy, National Taiwan University

Locations

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201801017RINA

Identifier Type: -

Identifier Source: org_study_id