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NCT00569530 · ClinicalTrials.gov registry record · Phase 3
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
A Phase 3 study of Bronchopulmonary Dysplasia and Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), sponsored by Roberta Ballard.
- Completed
- Registry status
- Phase 3
- Development phase
- 85
- Enrollment target
- 9
- Study locations
NCT00569530: Completed Phase 3 study of Bronchopulmonary Dysplasia and Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), sponsored by Roberta Ballard.
NCT00569530 is a Phase 3 study of Bronchopulmonary Dysplasia and Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) that has completed, run by Roberta Ballard. The registered enrollment target is 85 participants, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (64% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00569530, a Phase 3 study of Bronchopulmonary Dysplasia and Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), has completed, sponsored by Roberta Ballard.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 85 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
Primary Outcome
SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.
Conditions Studied
Interventions
- DRUG Sham
- DRUG Infasurf (ONY Inc.)
Study Locations (9)
California
- Alta Bates Summit Medical Center - Berkeley
- Children's Hospital Oakland - Oakland
- University of California, San Francisco - San Francisco
Illinois
- Northwestern Memorial Hospital - Chicago
- Children's Memorial Hospital - Chicago
New York
- Women and Children's Hospital of Buffalo - Buffalo
- Stony Brook University Medical Center - Stony Brook
Missouri
- Children's Mercy Hospital - Kansas City
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT00569530 record still lists
NCT00569530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.
NCT00569530 lists 9 locations in 5 states (California, Illinois, New York).
Frequently Asked Questions
What is clinical trial NCT00569530 about?
NCT00569530 is a clinical study titled "Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide". The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
What is the current status of trial NCT00569530?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 2008-01. Estimated completion is 2012-12.
What conditions does trial NCT00569530 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction).
What interventions are being tested in trial NCT00569530?
The interventions under investigation include: Sham (DRUG), Infasurf (ONY Inc.) (DRUG).
Who is sponsoring clinical trial NCT00569530?
This trial is sponsored by Roberta Ballard, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00569530 being conducted?
This trial has 9 study locations across California, Illinois, Missouri, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bronchopulmonary Dysplasia
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 NCT00569530's enrollment target sits among peer trials
85 21st of 29 higher than 9 of 29 other Bronchopulmonary Dysplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bronchopulmonary Dysplasia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Hydrocortisone for BPD
COMPLETED · Phase 3
-
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
COMPLETED · Phase 3
-
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
COMPLETED · Phase 3
-
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
RECRUITING · NA
-
Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
RECRUITING
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Genesis Electrical Impedance Tomography (EIT): A Preliminary Study
RECRUITING
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