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Prematurity and Respiratory Outcomes Program (PROP)
NCT01435187 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01435187
The ClinicalTrials.gov registry entry for NCT01435187 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 835 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Prematurity appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01435187 reports 13 study locations spanning 8 distinct geographic areas — top geographies include Ohio, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01435187?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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