Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide (TOLSURFPilot)
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ClinicalTrials.gov Identifier: NCT00569530 |
Recruitment Status :
Completed
First Posted : December 7, 2007
Results First Posted : June 28, 2016
Last Update Posted : May 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) Bronchopulmonary Dysplasia | Drug: Infasurf (ONY Inc.) Drug: Sham | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
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Active Comparator: Treatment Surfactant (Infasurf) ONY, NY
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
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Drug: Infasurf (ONY Inc.)
Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.
Other Name: Infasurf |
Placebo Comparator: Sham (no treatment)
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
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Drug: Sham
Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.
Other Name: Air |
- SP-B Content [ Time Frame: One day after dose ]SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.
- Alive Without BPD at 36 Weeks Post Menstrual Age [ Time Frame: 36 Weeks Post Menstrual Age ]Alive without need for oxygen at 36 weeks post menstrual age.

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Ages Eligible for Study: | 7 Days to 14 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Less than or equal to 1000 gm. birth weight
- Less than or equal to 30 weeks gestational age
- Day 7-14 of life
- Intubated and mechanically ventilated at any time days 7-14 of life
Exclusion Criteria:
- Serious congenital malformations
- Life expectancy less than 7 days from enrollment
- Previous treatment with iNO
- Active pulmonary hemorrhage at time of enrollment
- Active air leak syndrome at time of enrollment
- Bilateral grade IV intracranial hemorrhage prior to enrollment
- Less than 48 hours from last clinical dose of early surfactant.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569530
United States, California | |
Alta Bates Summit Medical Center | |
Berkeley, California, United States, 94705 | |
Children's Hospital Oakland | |
Oakland, California, United States, 94609 | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Illinois | |
Northwestern Memorial Hospital | |
Chicago, Illinois, United States, 60611 | |
Children's Memorial Hospital | |
Chicago, Illinois, United States, 60614 | |
United States, Missouri | |
Children's Mercy Hospital | |
Kansas City, Missouri, United States, 64108 | |
United States, New York | |
Women and Children's Hospital of Buffalo | |
Buffalo, New York, United States, 14222 | |
Stony Brook University Medical Center | |
Stony Brook, New York, United States, 11794 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Roberta A Ballard, MD | University of California, San Francisco |
Responsible Party: | Roberta Ballard, Principal Investigator, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00569530 |
Other Study ID Numbers: |
H10842-31630-01 IND79367 ( Other Identifier: FDA ) |
First Posted: | December 7, 2007 Key Record Dates |
Results First Posted: | June 28, 2016 |
Last Update Posted: | May 11, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
nitric oxide surfactant bronchopulmonary dysplasia prematurity neonates |
iNO Infasurf lung function ventilated infants |
Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Bronchopulmonary Dysplasia Premature Birth Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Ventilator-Induced Lung Injury Lung Injury Calfactant Pulmonary Surfactants Respiratory System Agents |