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| Name | Class |
|---|---|
| National Health Research Institutes, Taiwan | OTHER |
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Four hypotheses will be tested in this study:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-centered intervention program | Experimental | 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. |
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| Usual care intervention program | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-centered intervention program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Child: neurodevelopment functions (cognition, language and motor) | Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition | 24 months of corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 months of corrected age |
| Child: neurodevelopment functions (behavior) |
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Inclusion Criteria:
Exclusion Criteria:
Terminated Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suh-Fang Jeng, Professor | School and Graduate Institute of Physical Therapy, National Taiwan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan | |||
| National Taiwan University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35921693 | Derived | 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. | |
| 31504897 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Usual care intervention program | Behavioral | 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. |
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|
Child behavior checklist version 1.5-5 Y 2. World Health Organization Quality of Life- Brief Taiwan version |
| 24 months of corrected age |
| 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 | 6,12, and 24 months |
| Parental functions and change from baseline (pressure) | Parenting Stress Index 2. World Health Organization Quality of Life- Brief Taiwan version | 0, 6, 12, 18, and 24 months of corrected age |
| Parental functions and change from baseline (Quality of Life) | World Health Organization Quality of Life- Brief Taiwan version | 0, 6, 12, 18, and 24 months of corrected age |
| Transactional functions and change from baseline | Mother-infant interaction in free play at 6, 12, and 18 months of corrected age | 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 | 6 and 12 months of corrected age |
| Transactions function: affordance | 1. Affordances in the Home Environment Motor Development- Chinese version | 18 months of corrected age |
| Child: Medical data | Chart review | Birth to 24 months of corrected age |
| Child: growth data and change from baseline | Chart review and measurement | 0, 1, 4, 6, 12, 18, and 24 months of corrected age |
| Child: neurophysiological functions and change from baseline | Electroencephalogram/event-related potential | 1 and 4 months of corrected age |
| Child: genotyping and gene expression | Buccal cell collection | 0 month of corrected age |
| Parental adherence to Intervention | Only assessed in FCIP group
| 32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months |
| Taipei |
| 100 |
| Taiwan |
| Mackay Memorial Hospital | Taipei | 104 | Taiwan |
| D000091642 | Urogenital Diseases |