Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia (TOLSURF)
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|ClinicalTrials.gov Identifier: NCT01022580|
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : May 13, 2021
Last Update Posted : May 13, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Bronchopulmonary Dysplasia||Drug: Infasurf surfactant (ONY, Inc.) Drug: Sham (No Treatment)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||511 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia: A Study in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2016|
Active Comparator: Infasurf surfactant (ONY, Inc.)
Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.
Drug: Infasurf surfactant (ONY, Inc.)
Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Other Name: Treatment
Sham Comparator: Sham (No Treatment)
Infants already receiving inhaled nitric oxide will receive "Sham (no treatment)" doses on study days 0,2,4,6, and 8.
Drug: Sham (No Treatment)
Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Other Name: Control
- Survival Without BPD at 36 Weeks Post Menstrual Age. [ Time Frame: 36 weeks post menstrual age +/- 1 week ]BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction.
- Survival Without BPD at 40 Weeks [ Time Frame: 40 weeks PMA +/- 1 week ]BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction.
- Respiratory Outcomes of TOLSURF Infants at 1 Year Corrected Age [ Time Frame: 1 year ]Evaluation of respiratory outcome through the first 12 months after birth. questionnaires were administered by phone at 3,6,9 and 12 months to determine respiratory resource use (medications, home support, and hospitalization) No Pulmonary Morbidity (NoPM) was reported for infants who had no resource use in any quarter and Persistent PM was reported for infants having resource use in 3 or 4 quarters.
- Pulmonary Outcomes Through 2 Years of Age [ Time Frame: 2 years ]Evaluation of pulmonary outcome at 24 months of age. Evaluation of persistent wheezing based on reported wheezing during both first and second year of life.
- Percentage of Participants With Neurodevelopmental Impairment (NDI) at 2 Years. [ Time Frame: 2 years ]At 24 months corrected age, children underwent neuropsychological testing with the Bayley Scales of Infant Development-Third Edition (Bayley-3), and composite cognitive, language, and motor scores were collected as well as subscale scores in receptive and expressive speech and fine and gross motor. Infants with greater than one impairment as identified by testing were classified as having neurodevelopmental impairment.
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|Ages Eligible for Study:||7 Days to 14 Days (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- <=28 0/7 weeks gestational age
- Day of life 7-14
- Intubated and mechanically ventilated
- Plan to treat with inhaled nitric oxide
- Serious congenital malformations or chromosomal abnormalities
- Life expectancy <7 days from enrollment
- Clinically unstable
- Less tha 48 hours since last dose surfactant
- Ability to obtain 36 week primary outcome information is unlikely
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): NCT01022580
|Principal Investigator:||Roberta A Ballard, MD||University of California, San Francisco|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Roberta Ballard, Professor of Pediatrics, University of California, San Francisco|
|Other Study ID Numbers:||
U01HL094338 ( U.S. NIH Grant/Contract )
|First Posted:||December 1, 2009 Key Record Dates|
|Results First Posted:||May 13, 2021|
|Last Update Posted:||May 13, 2021|
|Last Verified:||April 2021|
Ventilator-Induced Lung Injury
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiratory System Agents