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NCT01435187 · ClinicalTrials.gov registry record
Prematurity and Respiratory Outcomes Program (PROP)
A clinical trial of Prematurity and Respiratory Disease, sponsored by University of Pennsylvania.
- Completed
- Registry status
- 835
- Enrollment target
- 13
- Study locations
NCT01435187: Completed study of Prematurity and Respiratory Disease, sponsored by University of Pennsylvania.
NCT01435187 is a study of Prematurity and Respiratory Disease that has completed, run by University of Pennsylvania. The registered enrollment target is 835 participants, above the 171-participant average among 21 other Prematurity trials with a reported enrollment target (388% higher). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01435187, a study of Prematurity and Respiratory Disease, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- 835 participants
- Enrollment target
- 13
- Study locations
Study 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 morbidity as defined by respiratory health care utilization and respiratory symptoms, between discharge and 1 year corrected age. This protocol describes a collaboratively developed multicenter study of very preterm infants from birth through the time of discharge from the Neonatal Intensive Care Unit (NICU) and up to 1 year of age, corrected for the degree of prematurity.
Primary Outcome
The primary goal of the PROP studies (single center and multicenter protocols) is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age.
Conditions Studied
Study Locations (13)
Ohio
- Cincinnati University Hospital - Cincinnati
- Good Samaritan Hospital - Cincinnati
- Cincinnati Children's Hospital - Cincinnati
California
- Alta Bates Summit Medical Center - Oakland
- University of California, San Francisco - San Francisco
New York
- University of Buffalo - Buffalo
- University of Rochester - Rochester
Tennessee
- Jackson-Madison County General Hospital - Jackson
- Monroe Carell Jr Children's Hospital at Vanderbilt - Nashville
Indiana
- Indiana University Health/Riley Hospital for Children - Indianapolis
Missouri
- Washington Universitiy - St Louis
North Carolina
- Duke University Medical Center - Durham
Texas
- University of Texas, Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 835 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-03 |
What the finished NCT01435187 record still lists
NCT01435187 is an observational study that tracks outcomes without assigning an intervention. The registered 835 participants enrollment target is mid-sized for trials with a published cap, above the 171-participant average among 21 other Prematurity trials with a reported enrollment target (388% higher).
The record links to 2 conditions, with Prematurity appearing as the primary indexed condition, and to 0 interventions.
NCT01435187 lists 13 locations in 8 states (Ohio, California, New York).
Frequently Asked Questions
What is clinical trial NCT01435187 about?
NCT01435187 is a clinical study titled "Prematurity and Respiratory Outcomes Program (PROP)". 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 morbidity as defined by respiratory health care utilization and respiratory symptoms, between discharge and ...
What is the current status of trial NCT01435187?
This trial is currently completed. The enrollment target is 835 participants. The study started on 2011-08. Estimated completion is 2016-03.
What conditions does trial NCT01435187 study?
This clinical trial studies the following conditions: Prematurity, Respiratory Disease.
Who is sponsoring clinical trial NCT01435187?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01435187 being conducted?
This trial has 13 study locations across California, Indiana, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01435187's enrollment target sits among peer trials
835 1st of 21 higher than 21 of 21 other Prematurity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prematurity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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