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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roberta Ballard, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01022580
First received: November 19, 2009
Last updated: September 20, 2013
Last verified: September 2013

November 19, 2009
September 20, 2013
January 2010
December 2013   (final data collection date for primary outcome measure)
Survival without BPD at 36 weeks post menstrual age. [ Time Frame: 36 weeks post menstrual age +/- 1 week ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01022580 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia: A Study in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Bronchopulmonary Dysplasia
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.
  • 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.
    Intervention: Drug: Infasurf surfactant (ONY, Inc.)
  • Sham Comparator: sham
    Infants already receiving inhaled nitric oxide will not receive additional doses of late surfactant (Infasurf).
    Intervention: Drug: Infasurf surfactant (ONY, Inc.)
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
524
July 2015
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 14 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01022580
H10842-33541-01A, U01HL094338
Yes
Roberta Ballard, University of California, San Francisco
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Roberta A Ballard, MD University of California, San Francisco
University of California, San Francisco
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP