Status:
COMPLETED
Prematurity and Respiratory Outcomes Program (PROP)
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Prematurity
Respiratory Disease
Eligibility:
All Genders
1-7 years
Brief Summary
In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic, physiologic and clinical data obtained during the initial hospitalization will predict respiratory morbidit...
Detailed Description
The primary goal of the PROP studies is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary sta...
Eligibility Criteria
Inclusion
- Infants who are less than or equal to 7 days old
- Gestational Age (GA) between 23 weeks and 0/7 days and 28 weeks and 6/7 days
Exclusion
- Infants who meet any of the following conditions will be excluded from the PROP cohort:
- The infant is not considered to be viable (decision made not to provide life-saving therapies)
- Congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
- Structural abnormalities of the upper airway, lungs or chest wall
- Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
- Family is unlikely to be available for long-term follow-up
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
835 Patients enrolled
Trial Details
Trial ID
NCT01435187
Start Date
August 1 2011
End Date
March 1 2016
Last Update
November 7 2016
Active Locations (13)
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1
Alta Bates Summit Medical Center
Oakland, California, United States, 94609
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Indiana University Health/Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
4
Washington Universitiy
St Louis, Missouri, United States, 63130