Status:
COMPLETED
A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Health Research Institutes, Taiwan
Conditions:
Premature Birth
Eligibility:
All Genders
Up to 36 years
Phase:
NA
Brief Summary
Four hypotheses will be tested in this study: 1. The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period. 2. The inter...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 22 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2017
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT01807533
Start Date
May 22 2012
End Date
January 10 2017
Last Update
August 24 2018
Active Locations (3)
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1
National Cheng Kung University Hospital
Tainan, Taiwan, 704
2
National Taiwan University Hospital
Taipei, Taiwan, 100
3
Mackay Memorial Hospital
Taipei, Taiwan, 104