Status:
COMPLETED
Early Intervention for Preterm Infants
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University
National Health Research Institutes, Taiwan
Conditions:
Premature Birth
Eligibility:
All Genders
Up to 7 years
Phase:
NA
Brief Summary
The first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at ...
Detailed Description
Preterm birth with very low birth weight (VLBW) (gestational age \<37 weeks and birth weight \<1,501 g) is a significant public health problem worldwide. Longitudinal follow-up studies showed that VLB...
Eligibility Criteria
Inclusion
- Inclusion Criteria for preterm infants:
- BW below 1,501 gm
- GA under 37 weeks
- Admission to the NICU within the first 7 days of life
- Physiologically stable at PCA 36 weeks as diagnosed by attending physician
- Hospital discharge prior to PCA 40 weeks
- Absence of congenital anomalies and/or severe neonatal diseases
- Family residence in the greater Taipei area.
- Exclusion Criteria for preterm infants:
- Severe neonatal diseases included major neurologic abnormalities (such as seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage, and grade IV retinopathy of prematurity)
- Necrotizing enterocolitis with colostomy
- Severe cardiopulmonary disease requiring daily oxygen use at hospital discharge
- Inclusion Criteria for full-term infants:
- Birth weight \>2,500 g;
- Gestational age within 38-42 weeks,
- Family living in the same geographic region as those of the VLBW preterm infants
- Exclusion Criteria for full-term infants:
- Serious prenatal or perinatal complications
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00173108
Start Date
January 1 2006
End Date
October 1 2010
Last Update
April 22 2011
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taipei, Taiwan, 100