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
  Purpose

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 Intervention Phase
Bronchopulmonary Dysplasia
Drug: Infasurf surfactant (ONY, Inc.)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Survival without BPD at 36 weeks post menstrual age. [ Time Frame: 36 weeks post menstrual age +/- 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 524
Study Start Date: January 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022580

Locations
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
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
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
Investigators
Principal Investigator: Roberta A Ballard, MD University of California, San Francisco
  More Information

No publications provided

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
Study First Received: November 19, 2009
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
nitric oxide
surfactant
bronchopulmonary dysplasia
BPD
prematurity
neonates
iNO
pulmonary outcome
neurodevelopmental outcome
Infasurf
lung function
Surfactant Dysfunction
Bronchopulmonary Dysplasia

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

ClinicalTrials.gov processed this record on October 23, 2014