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

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Family-centered intervention program (FCIP)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Premature Birth focused on measuring intervention, effectiveness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School and Graduate Institute of Physical Therapy, National Taiwan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

Term infants

Usual care program (UCP)

Family-centered intervention program (FCIP)

Arm Description

Healthy term infants

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Child: Past medical history
Past 1-year medical history is recorded by parental interview.
Child: Academic performance
Parent interview
Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition
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.
Child: Electroencephalogram (EEG)
Electroencephalogram (EEG) will be measured in the resting state for the participating children at 7 years of age.
Child: Event-related potential (ERP)
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.
Parent function-pressure
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.
Parent function-quality of Life
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.
Child: Behavior - Child Behavior Check List/ 4-18
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.
Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV
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.
Child: Growth - weight
weight will be assessed using an electric weight scale (kg)
Child: Growth - height
height will be assessed by the tape measure in standing position (cm)
Child: Growth - head circumference
head circumference will be assessed as the largest dimension around the head obtained with a type measure placed snugly above the ears (cm)

Full Information

First Posted
August 28, 2018
Last Updated
September 19, 2022
Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03668626
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
intervention, effectiveness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Term infants
Arm Type
No Intervention
Arm Description
Healthy term infants
Arm Title
Usual care program (UCP)
Arm Type
No Intervention
Arm Description
In-hospital and after-discharge intervention (telephone calls)
Arm Title
Family-centered intervention program (FCIP)
Arm Type
Experimental
Arm Description
In-hospital and after-discharge intervention (clinic and home visits)
Intervention Type
Other
Intervention Name(s)
Family-centered intervention program (FCIP)
Other Intervention Name(s)
early intervention program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child: Neurodevelopment- The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Child: Past medical history
Description
Past 1-year medical history is recorded by parental interview.
Time Frame
up to 2 years
Title
Child: Academic performance
Description
Parent interview
Time Frame
up to 2 years
Title
Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition
Description
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.
Time Frame
2 years
Title
Child: Electroencephalogram (EEG)
Description
Electroencephalogram (EEG) will be measured in the resting state for the participating children at 7 years of age.
Time Frame
2 years
Title
Child: Event-related potential (ERP)
Description
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.
Time Frame
2 years
Title
Parent function-pressure
Description
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.
Time Frame
2 years
Title
Parent function-quality of Life
Description
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.
Time Frame
2 years
Title
Child: Behavior - Child Behavior Check List/ 4-18
Description
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.
Time Frame
2 years
Title
Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV
Description
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
Time Frame: 1 year
Title
Child: Growth - weight
Description
weight will be assessed using an electric weight scale (kg)
Time Frame
up to 2 years
Title
Child: Growth - height
Description
height will be assessed by the tape measure in standing position (cm)
Time Frame
up to 2 years
Title
Child: Growth - head circumference
Description
head circumference will be assessed as the largest dimension around the head obtained with a type measure placed snugly above the ears (cm)
Time Frame
up to 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suh-Fang Jeng, Professor
Organizational Affiliation
School and Graduate Institute of Physical Therapy, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy, National Taiwan University
City
Taipei city
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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