Clinical trial NCT03668626: Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators
Official title: Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: intervention
effectiveness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2018-09-12
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Inclusion Criteria for Term infants:

* 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.

Primary outcomes:
measure: Child: Neurodevelopment- The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition
timeFrame: 2 years
Secondary outcomes:
measure: Child: Past medical history
timeFrame: up to 2 years
measure: Child: Academic performance
timeFrame: up to 2 years
measure: Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition
timeFrame: 2 years
measure: Child: Electroencephalogram (EEG)
timeFrame: 2 years
measure: Child: Event-related potential (ERP)
timeFrame: 2 years
measure: Parent function-pressure
timeFrame: 2 years
measure: Parent function-quality of Life
timeFrame: 2 years
measure: Child: Behavior - Child Behavior Check List/ 4-18
timeFrame: 2 years
measure: Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV
timeFrame: Time Frame: 1 year
measure: Child: Growth - weight
timeFrame: up to 2 years
measure: Child: Growth - height
timeFrame: up to 2 years
measure: Child: Growth - head circumference
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, National Taiwan University
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, National Taiwan University
name: Suh-Fang Jeng, Professor
role: PRINCIPAL_INVESTIGATOR
References: