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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 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.

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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.

Conditions Studied

Bronchopulmonary Dysplasia Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction)

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

FieldValue
Enrollment Target 85 participants
Start Date 2008-01
Est. Completion 2012-12
Phase Phase 3

Sponsor

Roberta Ballard

2 total trials

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What the Registry Record Tells You About NCT00569530

The ClinicalTrials.gov registry entry for NCT00569530 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (64% lower). The listed sponsor is Roberta Ballard, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.