- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03668626
Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei city, Taiwan, 100
- School and Graduate Institute of Physical Therapy, National Taiwan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Term infants
Healthy term infants
|
|
No Intervention: Usual care program (UCP)
In-hospital and after-discharge intervention (telephone calls)
|
|
Experimental: Family-centered intervention program (FCIP)
In-hospital and after-discharge intervention (clinic and home visits)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child: Neurodevelopment- The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition
Time Frame: 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child: Past medical history
Time Frame: up to 2 years
|
Past 1-year medical history is recorded by parental interview.
|
up to 2 years
|
Child: Academic performance
Time Frame: up to 2 years
|
Parent interview
|
up to 2 years
|
Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition
Time Frame: 2 years
|
The Movement Assessment Battery for Children- 2nd Edition examines the motor 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.
The scaled score of each subscale ranges from 1 to 19.
The total score is the sum of the raw scores of the subscales and can be converted to scaled score, ranging from 10 to 190, and percentile.
A higher score indicates a better performance.
|
2 years
|
Child: Electroencephalogram (EEG)
Time Frame: 2 years
|
Electroencephalogram (EEG) will be measured in the resting state for the participating children at 7 years of age.
|
2 years
|
Child: Event-related potential (ERP)
Time Frame: 2 years
|
Event-related potential (ERP) will be measured in the cognitive inhibitory control and working memory procedures and cognition/motor dual tasks with ERP technique for the participating children at 7 years of age.
|
2 years
|
Parent function-pressure
Time Frame: 2 years
|
Parenting Stress Index measures stress of parents of children aged 1 month to 12 years.
The total score ranges from 94 to 486, with a higher score indicating a higher stress.
|
2 years
|
Parent function-quality of Life
Time Frame: 2 years
|
World Health Organization Quality of Life- Brief Taiwan version has a total score ranging from 34 to 170.
A higher score indicates a better quality of life.
|
2 years
|
Child: Behavior - Child Behavior Check List/ 4-18
Time Frame: 2 years
|
The Child Behavior Check List/ 4-18 is a parent-report questionnaire designed to assess the behavior problems in children at 4 to 18 years of age.
The CBCL/4-18 consists of 138 items to assess child's behavioral/emotional problems.
The total score ranges from 0 to 200, with a higher score indicating a worse behavior.
|
2 years
|
Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV
Time Frame: Time Frame: 1 year
|
The Swanson, Nolan, and Pelham Questionnaire, version 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. The total score ranges from 0 to 73, a higher score indicating a worse performance. |
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201801017RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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