Status:
COMPLETED
Post-hospitalization Nursing Effectiveness (PHONE) Study
Lead Sponsor:
Wake Forest University
Conditions:
Bronchopulmonary Dysplasia
Prematurity
Eligibility:
All Genders
1-483 years
Phase:
PHASE3
Brief Summary
Based on success with telephone follow up for other groups of medically fragile infants, we designed an innovative model of post-hospital comprehensive and coordinated follow-up for infants with chron...
Detailed Description
METHODS Study design A randomized equivalence trial was designed to compare community-based follow up with medical-center based follow up. The primary outcome was assessed at one year adjusted age. S...
Eligibility Criteria
Inclusion
- Infants were eligible if they were born before 33 weeks gestational age, required supplemental oxygen at 36 weeks gestational age, and were discharged home after neonatal intensive care.
Exclusion
- Neonates who had major congenital anomalies and/ or had tracheostomy tubes were excluded. Also excluded were families in which the mother did not speak English, because the intervention depended on verbal communication with the nurse specialist, and families who lived more than 150 miles from our clinic because such families typically are referred to regional neonatal center closer to their home.
Key Trial Info
Start Date :
May 1 1996
Trial Type :
INTERVENTIONAL
End Date :
August 1 2000
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00314431
Start Date
May 1 1996
End Date
August 1 2000
Last Update
November 6 2017
Active Locations (1)
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1
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157