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Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia (TOLSURF)

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ClinicalTrials.gov Identifier: NCT01022580
Recruitment Status : Unknown
Verified September 2013 by Roberta Ballard, University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : December 1, 2009
Last Update Posted : September 24, 2013
Information provided by (Responsible Party):

Study Description
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.) Phase 3

Detailed Description:
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 20 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 524 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
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Sham Comparator: sham
Infants already receiving inhaled nitric oxide will not receive additional doses of late surfactant (Infasurf).
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.

Outcome Measures

Primary Outcome Measures :
  1. Survival without BPD at 36 weeks post menstrual age. [ Time Frame: 36 weeks post menstrual age +/- 1 week ]

Secondary Outcome Measures :
  1. a) discharge home or off respiratory support at 40 weeks post menstrual age b) measures of BPD severity c) pulmonary outcome after discharge d) pulmonary and neurodevelopmental outcomes through 2 years of age [ Time Frame: 22 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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

United States, Arkansas
University of Arkansas - Arkansas Childrens Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Alta Bates Medical Center
Berkeley, California, United States, 94705
Oakland Children's Hospital
Oakland, California, United States, 94609
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
Wolfson Children's Hospital and Shands HospitaL
Jacksonville, Florida, United States, 32207
Florida Hospital for Children
Orlando, Florida, United States, 32803
All Children's Hospital
St Petersburg, Florida, United States, 33701
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Minnesota
Childrens Hospital and Clinics of Minnesota- Minneapolis
Minneapolis, Minnesota, United States, 55404
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
Children's Hospital and Clinics of Minnesota - St Paul
St Paul, Minnesota, United States, 55102
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New York
Women's 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, North Carolina
Wake Forest University- Forsyth Hospital and Brenner Hospital
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Medical University of South Carolina(MUSC)
Charleston, South Carolina, United States, 29403
United States, Tennessee
UT Memphis- Memphis Medical Center
Memphis, Tennessee, United States, 38103-2807
United States, Texas
UT Houston Health Science Center
Houston, Texas, United States, 77030-1503
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Washington
University of Washington, Seattle
Seattle, Washington, United States, 98195-6320
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Roberta A Ballard, MD University of California, San Francisco
More Information

Ballard RA, Truog WE, Cnaan A, Martin RJ, Ballard PL, Merrill JD, Walsh MC, Durand DJ, Mayock DE, Eichenwald EC, Null DR, Hudak ML, Puri AR, Golombek SG, Courtney SE, Stewart DL, Welty SE, Phibbs RH, Hibbs AM, Luan X, Wadlinger SR, Asselin JM, Coburn CE; NO CLD Study Group. Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. N Engl J Med. 2006 Jul 27;355(4):343-53. Erratum in: N Engl J Med. 2007 Oct 4;357(14):1444-5. PMID: 16870913 Ballard PL, Merrill JD, Truog WE, Godinez RI, Godinez MH, McDevitt TM, Ning Y, Golombek SG, Parton LA, Luan X, Cnaan A, Ballard RA. Surfactant function and composition in premature infants treated with inhaled nitric oxide. Pediatrics. 2007 Aug;120(2):346-53. PMID: 17671061 Truog WE, Ballard PL, Norberg M, Golombek S, Savani RC, Merrill JD, Parton LA, Cnaan A, Luan X, Ballard RA; Nitric Oxide (to Prevent) Chronic Lung Disease Study Investigators. Inflammatory markers and mediators in tracheal fluid of premature infants treated with inhaled nitric oxide. Pediatrics. 2007 Apr;119(4):670-8. PMID: 17403837

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     History of Changes
Other Study ID Numbers: H10842-33541-01A
U01HL094338 ( U.S. NIH Grant/Contract )
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013

Keywords provided by Roberta Ballard, University of California, San Francisco:
nitric oxide
bronchopulmonary dysplasia
pulmonary outcome
neurodevelopmental outcome
lung function
Surfactant Dysfunction

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Nitric Oxide
Pulmonary Surfactants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents