Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide (TOLSURF Pilot)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bellerophon
ONY
Information provided by (Responsible Party):
Roberta L. Keller, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00569530
First received: December 5, 2007
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.


Condition Intervention Phase
Surfactant Dysfunction
Bronchopulmonary Dysplasia
Drug: Infasurf (ONY Inc.)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Increased SPB content [ Time Frame: One day after dose ] [ Designated as safety issue: No ]
    Keller, RL, Merrill JD, Black D, Steinhorn RH, Eichenwald EC, Durand DJ, Ryan RM, Truog WE, Courtney SE, Ballard PL, Ballard RA. Late Surfactant Replacement therapy Increases Surfactant Protein-B Content in a Randomized Pilot Study, Pediatric Research. 2012 Dec;72(6) 613-9. PMCID: PMC3548137


Secondary Outcome Measures:
  • Assess the effects of late Infasurf treatment on the respiratory status of the ventilated infants receiving inhaled nitric oxide. [ Time Frame: December 2014 ] [ Designated as safety issue: Yes ]
    The study is in the data analysis phase.


Estimated Enrollment: 110
Study Start Date: January 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14.
Drug: Infasurf (ONY Inc.)
Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14.
Other Name: Infasurf
Placebo Comparator: 2
Infants receiving inhaled nitric oxide will not receive additional doses of Infasurf.
Drug: Infasurf (ONY Inc.)
Infants will not receive additional doses of Infasurf.
Other Name: Infasurf

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Less than or equal to 1000 gm. birth weight
  • Less than or equal to 30 weeks gestational age
  • Day 7-14 of life
  • Intubated and mechanically ventilated at any time days 7-14 of life

Exclusion Criteria:

  • Serious congenital malformations
  • Life expectancy less than 7 days from enrollment
  • Previous treatment with iNO
  • Active pulmonary hemorrhage at time of enrollment
  • Active air leak syndrome at time of enrollment
  • Bilateral grade IV intracranial hemorrhage prior to enrollment
  • Less than 48 hours from last clinical dose of early surfactant.
  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: NCT00569530

Locations
United States, California
Alta Bates Summit Medical Center
Berkeley, California, United States, 94705
Children's Hospital Oakland
Oakland, California, United States, 94609
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New York
Women 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, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of California, San Francisco
Bellerophon
ONY
Investigators
Principal Investigator: Roberta A Ballard, MD University of California, San Francisco
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roberta L. Keller, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00569530     History of Changes
Other Study ID Numbers: H10842-31630-01, IND79367
Study First Received: December 5, 2007
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
nitric oxide
surfactant
bronchopulmonary dysplasia
prematurity
neonates
iNO
Infasurf
lung function
ventilated infants

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

ClinicalTrials.gov processed this record on September 29, 2014