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

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ClinicalTrials.gov Identifier: NCT03668626
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Premature Birth Other: Family-centered intervention program (FCIP) Not Applicable

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 25 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.

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Study Type : Interventional
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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)
Other: Family-centered intervention program (FCIP)
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 Name: early intervention program




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Child: Past medical history [ Time Frame: up to 2 years ]
    Past 1-year medical history is recorded by parental interview.

  2. Child: Academic performance [ Time Frame: up to 2 years ]
    Parent interview

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


  10. Child: Growth - weight [ Time Frame: up to 2 years ]
    weight will be assessed using an electric weight scale (kg)

  11. Child: Growth - height [ Time Frame: up to 2 years ]
    height will be assessed by the tape measure in standing position (cm)

  12. 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668626


Contacts
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Contact: Suh-Fang Jeng, Professor 886-2-33668132 jeng@ntu.edu.tw
Contact: Nai-Jia Yao, Master 886-2-33668132 d03428001@ntu.edu.tw

Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Investigators
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Principal Investigator: Suh-Fang Jeng, Professor School and Graduate Institute of Physical Therapy, National Taiwan University

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03668626     History of Changes
Other Study ID Numbers: 201801017RINA
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications