- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02533661
Effects of Family-Centered Intervention for Preterm Infants at Preschool Age
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Purposes:
This study is to extend our previous research to longitudinally examine the effectiveness of FCIP and UCP for VLBW preterm children in Taiwan at 3 and 4 years of age and to investigate if dopamine-related genes moderate intervention effect on child developmental outcome. Effectiveness examined will include child and parent outcomes. Child outcomes will consist of growth, health, neurodevelopment (cognition, language and motor function) and behavior. Parent outcomes will include parental stress and quality of life. The long-term effect of early intervention for preterm children from the neonatal period to preschool age will provide important information to help medical professionals and public policy makers to develop effective intervention for Taiwanese preterm children who are at risk of developmental problems. Furthermore, the genetic susceptibility theory and the cumulative genetic plasticity theory will be used to examine the relations of polymorphisms of dopamine-related genes with child development and their possible interactions with environmental intervention on child development. Over twenty dopamine genetic markers that were identified in extensive research as being associated with plasticity for neurodevelopmental functions will be examined for their individual and synergistic influences on developmental outcomes.
Participants:
Two hundred and seventy-five VLBW preterm children participating in our previous study who were born or admitted at National Taiwan University Hospital (NTUH), Mackay Memorial Hospital (MMH) and National Cheng Kung University Hospital (NCKUH) during the period of April 2012 to December 2014 will be enrolled in this study.
Methods:
All families will be contacted via phone call and mail to participate in this study. Children and their parents will be examined for the following outcomes when the children approach 3 and 4 years of age. All measures will be conducted at the Infant Motor Development Laboratory, School of Physical Therapy, National Taiwan University, and the Cognitive Electrophysiology Laboratory, Institute of Cognitive Science, National Cheng Kung University. The outcome measures in this study will consist of the primary child outcome (growth, health, neurodevelopment [cognitive, language and motor function] and behavior) and the secondary parent outcome (parental stress and quality of life). Child neurodevelopment will be examined using the Bayley Scales of Infant Development- 2nd edition, Bayley Scales of Infant and Toddler Development-3rd edition, Movement Assessment Battery for Children-2nd Edition, and Wechsler PreSchool and Primary Scales of Intelligence-4th Edition. Child behavior will be examined using the Children's Behavior Questionnaire, Swanson, Nolan, and Pelham Questionnaire- 4th Edition, and Child Behavior Check List/4-18. Parental stress will be assessed using the Parenting Stress Index-Long Form and quality of life will be assessed using the Chinese Version World Health Organization Quality of Life- Brief Taiwan Version. Each assessment will be delineated as follows.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zhongzheng District
-
Taipei, Zhongzheng District, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The inclusion criteria for VLBW preterm infants were:
- birth weight less than 1,500 gram
- gestational age lower than 37 weeks
The inclusion criteria for parents were:
- mothers older than 18 years of age;
- Taiwan nationality
- absence of maternal substance abuse (alcohol or drug)
- married or living together at delivery
- families residing in northern or southern Taiwan.
The exclusion criteria for VLBW preterm infants were:
- congenital abnormality
- severe neonatal and perinatal diseases: Severe neonatal diseases refer to major neurologic abnormalities (e.g., seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage and stage IV-V retinopathy of prematurity), necrotizing enterocolitis grade II and severe cardiopulmonary disease requiring daily oxygen use at hospital discharge that may require intensive developmental intervention and therefore did not suit for our interventions.
Furthermore, infants exhibiting persistently unstable physiological conditions until 36 weeks' PMA or older, being discharged from hospital at 44 weeks' PMA or older, or developing severe neonatal diseases were early terminated.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Family-centered intervention program
The FCIP group received:
|
This program will include in-hospital intervention, after-discharge intervention and neonatal follow-up.
Five sessions of in-hospital intervention will emphasize 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 will consist 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
Other Names:
|
No Intervention: Usual care program
The UCP group received:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child: Growth - weight
Time Frame: up to 2 years
|
weight will be assessed using an electric weight scale (kg)
|
up to 2 years
|
Child: Growth - height
Time Frame: up to 2 years
|
height will be assessed by the tape measure in standing position (cm)
|
up to 2 years
|
Child: Growth - head circumference
Time Frame: up to 2 years
|
head circumference will be assessed as the largest dimension around the head obtained with a type measure placed snugly above the ears (cm)
|
up to 2 years
|
Child: Health status
Time Frame: up to 2 years
|
Chart review
|
up to 2 years
|
Child: Neurodevelopment - Bayley Scale of Infant and Toddler Development- 2nd and 3rd Edition
Time Frame: 1 year
|
The BSID-II is a norm-referenced developmental diagnostic test for infants aged from 1 month to 42 months.
The assessment contains the Motor Scale (111 items), the Mental Scale (178 items), and the Behavioral Rating Scale (30 items).
|
1 year
|
Child: Neurodevelopment - The Wechsler Preschool and Primary Scale of Intelligence-Revised Edition
Time Frame: 1 year
|
The WPPSI-R measures cognitive development of children who aged from 3 to 7 years old.
The test structure of WPPSIR-IV includes 12 subscales and three levels of interpretation: full intelligence quotient (FIQ); performance intelligence quotient (PIQ), and verbal intelligence quotient (VIQ).
|
1 year
|
Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition
Time Frame: 1 year
|
The Movement ABC-II examines the movement performance in children aged 3 years to 16 years and 11 months.
The assessment contains eight items that measure a child's performance of age-appropriate tasks in the aspects of manual dexterity, aiming and catching, and balance.
|
1 year
|
Child: Behavior - Children's Behavior Questionnaire
Time Frame: 1 year
|
The CBQ is a parent-report temperament questionnaire for preschool- and school-aged children.
A total of 195 items described children's reactions on 15 primary temperament characteristics: positive anticipation, smiling/laughter, high intensity pleasure, activity level, impulsivity, shyness, discomfort, fear, anger/frustration, sadness, soothability, inhibitory control, attentional focusing, low intensity pleasure, and perceptual sensitivity.
|
1 year
|
Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV
Time Frame: 1 year
|
The SNAP-IV questionnaire examines the severity of ADHD and ODD in preschool- and school-aged children.
The scale employs the direct symptom of Diagnosis and Statistical Manual of Mental Disorder-IV (DSM-IV) that consists of inattention (nine items), hyperactivity/impulsivity (nine items) of the criteria for ADHD, and the oppositional symptoms (eight items) of the criteria for ODD.
|
1 year
|
Child: Behavior - Child Behavior Check List/1.5-5
Time Frame: 1 year
|
The CBCL/1.5-5 is a parent-report questionnaire designed to assess the behavior problems in children at 1.5 to 5 years of age.
The CBCL/1.5-5 consists of 99 items to assess concerning behavioral/emotional problems.
|
1 year
|
Child: Neurodevelopment - The Berry-Buktenica Developmental Test of Visual-Motor Integration
Time Frame: 1 year
|
The VMI screens for visual-motor deficits in children from 2 to 18 years old and adults.
The assessment contains visual-motor integration, visual perception and motor coordination.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent: Parental stress - Parenting Stress Index/ Long Form
Time Frame: 1 year
|
The PSI-LF is a self-report questionnaire that measures parenting stress based on interrelationship between the child's and the parents'characteristics.
The questionnaire has 101 items, rated on a 5-point Likert scale, and contains parental distress (PD), parent-child dysfunctional interaction (PCDI), and difficult child (DC) subscales.
|
1 year
|
Parent: Quality of life - World Health Organization Quality of Life- Brief Taiwan Version
Time Frame: 1 year
|
The WHOQOL-BREF-TW is a self-administered scale that examines the quality of life of an individual.
Twenty eight items are grouped into general QOL and general health; 26 items are classified into physical, psychological, social relationship and environment domains.
Items are scored from 1 to 5 on a Likert's scale.
|
1 year
|
Child: Neurophysiological functions
Time Frame: 1 year
|
Child's neurophysiological functions will be measured by the cognitive task (eg.
Go-Nogo task and oddball task) with electroencephalogram (EEG)/event-related potential (ERP) technique for the participating children at 4 years old.
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Suh-Fang Jeng, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201412127RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Premature Birth
-
Shaare Zedek Medical CenterTerminatedPremature Birth of NewbornIsrael
-
University of VirginiaCompletedPremature Birth of NewbornUnited States
-
Case Western Reserve UniversityCompleted
-
University of California, San FranciscoUniversity of California, San Diego; University of California, Los Angeles; Kaiser...CompletedPremature Birth of NewbornUnited States
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenUnknownPremature Birth of NewbornBelgium
-
Universidad Complutense de MadridCompletedPremature Birth of Newborn
-
Indiana UniversityCompletedPremature LaborUnited States
-
Washington University School of MedicineUniversity of Southern CaliforniaCompletedPremature Birth of NewbornUnited States
-
Vestre Viken Hospital TrustHaukeland University HospitalActive, not recruiting
-
University of ArkansasCompletedPremature Birth of NewbornUnited States
Clinical Trials on Family-centered intervention program
-
National Taiwan University HospitalNational Health Research Institutes, TaiwanCompleted
-
National Taiwan University HospitalNational Health Research Institutes, TaiwanCompleted
-
Ersta Sköndal University CollegeCompletedPalliative CareSweden
-
Children's National Research InstituteNational Institute of Nursing Research (NINR); National Institutes of Health... and other collaboratorsActive, not recruiting
-
Hasselt UniversityUniversity Ghent; Jimma University; PXL University CollegeCompletedSeverly Acutely Malnourished Children
-
wen yu Kuo, assistant professorChang Gung Memorial Hospital; National Science and Technology CouncilCompleted
-
Lawson Health Research InstituteTerminated
-
University of MichiganCompletedHigh Risk Population of Part-time Seatbelt Users
-
Community Volunteers In MedicineAmerican Academy of PediatricsCompletedPediatric Obesity | Overweight and Obesity
-
Göteborg UniversitySahlgren´s University HospitalCompletedFatigue | Rheumatoid ArthritisSweden