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

This study has been completed.
Sponsor:
Collaborators:
Mallinckrodt
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: May 18, 2016
Last verified: May 2016
  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
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction)
Bronchopulmonary Dysplasia
Drug: Infasurf (ONY Inc.)
Drug: Sham
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:
  • SP-B Content [ Time Frame: One day after dose ] [ Designated as safety issue: No ]
    SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.


Secondary Outcome Measures:
  • Alive Without BPD at 36 Weeks Post Menstrual Age [ Time Frame: 36 Weeks Post Menstrual Age ] [ Designated as safety issue: No ]
    Alive without need for oxygen at 36 weeks post menstrual age.


Enrollment: 85
Study Start Date: January 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Surfactant (Infasurf) ONY, NY
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Drug: Infasurf (ONY Inc.)
Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.
Other Name: Infasurf
Placebo Comparator: Sham (no treatment)
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Drug: Sham
Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.
Other Name: Air

Detailed Description:
Surfactant dysfunction my contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. We conducted a multi-center, randomized, blinded pilot study to assess the safety and efficacy of late administration of surfactant (Calfactant - high in protein B) in combination with prolonged inhaled nitric oxide in preterm infants < 1000 grams birthweight (BW). Calfactant is one of several types of exogenous surfactant. Calfactant has the highest % of surfactant protein B of the different types.
  Eligibility

Ages Eligible for Study:   up to 14 Days   (Child)
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
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
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
Mallinckrodt
ONY
Investigators
Principal Investigator: Roberta A Ballard, MD University of California, San Francisco
  More Information

Publications:
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
Results First Received: February 29, 2016
Last Updated: May 18, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Premature Birth
Bronchopulmonary Dysplasia
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Nitric Oxide
Calfactant
Pulmonary Surfactants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters

ClinicalTrials.gov processed this record on July 21, 2016