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Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
NCT01022580 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated infants.
Conditions Studied
Interventions
- DRUG Infasurf surfactant (ONY, Inc.)
- DRUG Sham (No Treatment)
Study Locations (20)
California
- Alta Bates Medical Center — Berkeley
- Oakland Children's Hospital — Oakland
- University of California, San Francisco — San Francisco
Florida
- Wolfson Children's Hospital and Shands HospitaL — Jacksonville
- Florida Hospital for Children — Orlando
- All Children's Hospital — St. Petersburg
Minnesota
- Childrens Hospital and Clinics of Minnesota- Minneapolis — Minneapolis
- University of Minnesota Medical School — Minneapolis
- Children's Hospital and Clinics of Minnesota - St Paul — Saint Paul
Illinois
- Northwestern Memorial Hospital — Chicago
- Children's Memorial Hospital — Chicago
New York
- Women's and Children's Hospital of Buffalo — Buffalo
- Stony Brook University Medical Center — Stony Brook
Texas
- UT Houston Health Science Center — Houston
- Texas Children's Hospital — Houston
Arkansas
- University of Arkansas - Arkansas Childrens Hospital — Little Rock
Missouri
- Children's Mercy Hospital — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01022580
The ClinicalTrials.gov registry entry for NCT01022580 describes a study currently listed as completed. It is categorized as Phase 3, 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 511 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roberta Ballard, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions — of which Infasurf surfactant (ONY, Inc.) is the first listed. 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: NCT01022580 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Minnesota. 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 NCT01022580 about?
NCT01022580 is a clinical study titled "Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia". The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated infants.
What is the current status of trial NCT01022580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2010-01. Estimated completion is 2016-01.
What conditions does trial NCT01022580 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01022580?
The interventions under investigation include: Infasurf surfactant (ONY, Inc.) (DRUG), Sham (No Treatment) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01022580?
This trial is sponsored by Roberta Ballard, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01022580 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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