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A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways

Primary Purpose

Premature Birth

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

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring Environment, Gene, Intervention, Neurodevelopment, Pathways, Preterm infants

Eligibility Criteria

undefined - 36 Weeks (Child)All SexesDoes not accept 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

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:

  • 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

  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Family-centered intervention program

Usual care intervention program

Arm Description

FCIP: family members were encouraged to present in all intervention sessions included 5 in-hospital intervention, 7 after-discharge interventions (0, 1, 2, 4, 6, 9, and 12 months of corrected age), and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.

UCP: family members were invited to present at least one session of the 5 in-hospital intervention session. Parents and infants in the UCP group received 7 after-discharge phone calls (0, 1, 2, 4, 6, 9, and 12 months of corrected age) and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.

Outcomes

Primary Outcome Measures

Child: neurodevelopment functions (cognition, language and motor)
Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition

Secondary Outcome Measures

Change of neurodevelopment functions (motor) from baseline
The Neonatal Neurobehavioral Examination-Chinese Version (NNE-C) 2. World Health Organization Quality of Life- Brief Taiwan version
Child: neurodevelopment functions (behavior)
Child behavior checklist version 1.5-5 Y 2. World Health Organization Quality of Life- Brief Taiwan version
Change of neurodevelopment functions (cognition, language and motor) from baseline
Bayley Scales of Infant and Toddler Development - 3rd edition 2. World Health Organization Quality of Life- Brief Taiwan version
Parental functions and change from baseline (pressure)
Parenting Stress Index 2. World Health Organization Quality of Life- Brief Taiwan version
Parental functions and change from baseline (Quality of Life)
World Health Organization Quality of Life- Brief Taiwan version
Transactional functions and change from baseline
Mother-infant interaction in free play at 6, 12, and 18 months of corrected age
Transactional functions and change from baseline
Wakeful Position Questionnaire at 6 and 12 months of corrected age
Transactions function: affordance
1. Affordances in the Home Environment Motor Development- Chinese version
Child: Medical data
Chart review
Child: growth data and change from baseline
Chart review and measurement
Child: neurophysiological functions and change from baseline
Electroencephalogram/event-related potential
Child: genotyping and gene expression
Buccal cell collection
Parental adherence to Intervention
Only assessed in FCIP group Parental motivation Goal attainment Home activity records

Full Information

First Posted
January 29, 2013
Last Updated
August 22, 2018
Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01807533
Brief Title
A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
Official Title
A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 22, 2012 (Actual)
Primary Completion Date
January 10, 2017 (Actual)
Study Completion Date
January 10, 2017 (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
Yes

5. Study Description

Brief Summary
Four hypotheses will be tested in this study: The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period. The intervention group shows greater changes in early neurophysiological brain functions and transactions within the family that lead to better neurodevelopmental outcomes than the control group. Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants. Very low birth weight preterm infants carrying more genetic plasticity in the dopamine-related genes may benefit more from the interventions than those carrying less genetic plasticity.
Detailed Description
A total of 275 VLBW preterm infants (269 participants and 6 pilots) were recruited at three medical centers in northern and southern Taiwan and were randomly assigned to the FCIP or UCP group. Outcome assessments included primary (neurobehavioral development) and secondary measures (neurophysiological performance, parents' stress and transactions within the family). The neurophysiological and transactions data were examined for whether they mediate intervention effects on child development. In addition, these infants 219 VLBW preterm infants and 118 term infants in our prior intervention studies were collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensorimotor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses. The polymorphisms of dopamine-related genes were examined for potential moderating influence on the effects of the intervention for child development.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Environment, Gene, Intervention, Neurodevelopment, Pathways, Preterm infants

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family-centered intervention program
Arm Type
Experimental
Arm Description
FCIP: family members were encouraged to present in all intervention sessions included 5 in-hospital intervention, 7 after-discharge interventions (0, 1, 2, 4, 6, 9, and 12 months of corrected age), and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.
Arm Title
Usual care intervention program
Arm Type
Other
Arm Description
UCP: family members were invited to present at least one session of the 5 in-hospital intervention session. Parents and infants in the UCP group received 7 after-discharge phone calls (0, 1, 2, 4, 6, 9, and 12 months of corrected age) and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.
Intervention Type
Behavioral
Intervention Name(s)
Family-centered intervention program
Other Intervention Name(s)
FCIP
Intervention Description
This program was in-hospital intervention, after-discharge intervention, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. 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
Intervention Type
Behavioral
Intervention Name(s)
Usual care intervention program
Other Intervention Name(s)
UCP
Intervention Description
This program was in-hospital intervention, after-discharge consultation, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. The after-discharge service was provided 7-phone calls for the general health consultation.
Primary Outcome Measure Information:
Title
Child: neurodevelopment functions (cognition, language and motor)
Description
Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition
Time Frame
24 months of corrected age
Secondary Outcome Measure Information:
Title
Change of neurodevelopment functions (motor) from baseline
Description
The Neonatal Neurobehavioral Examination-Chinese Version (NNE-C) 2. World Health Organization Quality of Life- Brief Taiwan version
Time Frame
0 months of corrected age
Title
Child: neurodevelopment functions (behavior)
Description
Child behavior checklist version 1.5-5 Y 2. World Health Organization Quality of Life- Brief Taiwan version
Time Frame
24 months of corrected age
Title
Change of neurodevelopment functions (cognition, language and motor) from baseline
Description
Bayley Scales of Infant and Toddler Development - 3rd edition 2. World Health Organization Quality of Life- Brief Taiwan version
Time Frame
6,12, and 24 months
Title
Parental functions and change from baseline (pressure)
Description
Parenting Stress Index 2. World Health Organization Quality of Life- Brief Taiwan version
Time Frame
0, 6, 12, 18, and 24 months of corrected age
Title
Parental functions and change from baseline (Quality of Life)
Description
World Health Organization Quality of Life- Brief Taiwan version
Time Frame
0, 6, 12, 18, and 24 months of corrected age
Title
Transactional functions and change from baseline
Description
Mother-infant interaction in free play at 6, 12, and 18 months of corrected age
Time Frame
6, 12, and 18 months of corrected age
Title
Transactional functions and change from baseline
Description
Wakeful Position Questionnaire at 6 and 12 months of corrected age
Time Frame
6 and 12 months of corrected age
Title
Transactions function: affordance
Description
1. Affordances in the Home Environment Motor Development- Chinese version
Time Frame
18 months of corrected age
Title
Child: Medical data
Description
Chart review
Time Frame
Birth to 24 months of corrected age
Title
Child: growth data and change from baseline
Description
Chart review and measurement
Time Frame
0, 1, 4, 6, 12, 18, and 24 months of corrected age
Title
Child: neurophysiological functions and change from baseline
Description
Electroencephalogram/event-related potential
Time Frame
1 and 4 months of corrected age
Title
Child: genotyping and gene expression
Description
Buccal cell collection
Time Frame
0 month of corrected age
Title
Parental adherence to Intervention
Description
Only assessed in FCIP group Parental motivation Goal attainment Home activity records
Time Frame
32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
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 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: 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
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35921693
Citation
Li SJ, Tsao PN, Tu YK, Hsieh WS, Yao NJ, Wu YT, Jeng SF. Cognitive and motor development in preterm children from 6 to 36 months of age: Trajectories, risk factors and predictability. Early Hum Dev. 2022 Sep;172:105634. doi: 10.1016/j.earlhumdev.2022.105634. Epub 2022 Jul 28.
Results Reference
derived
PubMed Identifier
31504897
Citation
Yu YT, Huang WC, Hsieh WS, Chang JH, Lin CH, Hsieh S, Lu L, Yao NJ, Fan PC, Lee CL, Tu YK, Jeng SF. Family-Centered Care Enhanced Neonatal Neurophysiological Function in Preterm Infants: Randomized Controlled Trial. Phys Ther. 2019 Dec 16;99(12):1690-1702. doi: 10.1093/ptj/pzz120.
Results Reference
derived

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A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways

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