Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia (TOLSURF)
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| ClinicalTrials.gov Identifier: NCT01022580 |
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Recruitment Status :
Completed
First Posted : December 1, 2009
Results First Posted : May 13, 2021
Last Update Posted : May 13, 2021
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Sponsor:
Roberta Ballard
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roberta Ballard, University of California, San Francisco
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bronchopulmonary Dysplasia | Drug: Infasurf surfactant (ONY, Inc.) Drug: Sham (No Treatment) | Phase 3 |
This is a multi-center, blinded, randomized controlled clinical trial to evaluate the effects of booster doses of exogenous surfactant (Infasurf®, calfactant) in addition to inhaled nitric oxide (iNO) on the outcome of survival without bronchopulmonary dysplasia (BPD, or chronic lung disease of prematurity, characterized by chronic lung dysfunction) at 36 weeks' post-menstrual age (PMA) in extremely low gestational age (ELGAN) infants that are at high risk of the development of BPD. This multi-center trial, with a planned enrollment of 524 infants, will also enable us to evaluate for any adverse effects of late surfactant treatment on short- and long-term outcomes, as we will be collecting data on effects of dosing of late surfactant, co-morbidities of prematurity and neurodevelopmental and pulmonary outcome at 1 year and 24 months corrected age. In addition, we will collect biological specimens for evaluation of the effects of late surfactant replacement therapy (administered as described in this trial) on surfactant function and inflammatory markers.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 511 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Calfactant
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 |
Criteria
Inclusion Criteria:
- <=28 0/7 weeks gestational age
- Day of life 7-14
- Intubated and mechanically ventilated
- Plan to treat with inhaled nitric oxide
Exclusion Criteria:
- 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
Information from the National Library of Medicine
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
Locations
Show 21 study locations
Sponsors and Collaborators
Roberta Ballard
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Roberta A Ballard, MD | University of California, San Francisco |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Roberta Ballard, Professor of Pediatrics, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01022580 |
| Other Study ID Numbers: |
H10842-33541-01A 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 |
Keywords provided by Roberta Ballard, University of California, San Francisco:
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nitric oxide surfactant BPD prematurity neonates iNO |
pulmonary outcome neurodevelopmental outcome Infasurf lung function Surfactant Dysfunction Bronchopulmonary Dysplasia |
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia Hyperplasia Pathologic Processes Ventilator-Induced Lung Injury Lung Injury Lung Diseases |
Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Pulmonary Surfactants Calfactant Respiratory System Agents |