Premature Birth Clinical Trial
Official title:
Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators
Verified date | September 2022 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 320 |
Est. completion date | December 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | School and Graduate Institute of Physical Therapy, National Taiwan University | Taipei city |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | National Health Research Institutes, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | |
Secondary | Child: Past medical history | Past 1-year medical history is recorded by parental interview. | up to 2 years | |
Secondary | Child: Academic performance | Parent interview | up to 2 years | |
Secondary | 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. | 2 years | |
Secondary | Child: Electroencephalogram (EEG) | Electroencephalogram (EEG) will be measured in the resting state for the participating children at 7 years of age. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. |
Time Frame: 1 year | |
Secondary | Child: Growth - weight | weight will be assessed using an electric weight scale (kg) | up to 2 years | |
Secondary | Child: Growth - height | height will be assessed by the tape measure in standing position (cm) | up to 2 years | |
Secondary | 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) | up to 2 years |
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