Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide - Full Text View

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:

Genetics Home Reference related topics: pulmonary alveolar microlithiasis surfactant dysfunction

Drug Information available for: Nitric oxide

Genetic and Rare Diseases Information Center resources: Bronchopulmonary Dysplasia

U.S. FDA Resources

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:

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.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Keller RL, Merrill JD, Black DM, Steinhorn RH, Eichenwald EC, Durand DJ, Ryan RM, Truog WE, Courtney SE, Ballard PL, Ballard RA. Late administration of surfactant replacement therapy increases surfactant protein-B content: a randomized pilot study. Pediatr Res. 2012 Dec;72(6):613-9. doi: 10.1038/pr.2012.136. Epub 2012 Oct 4.


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 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 February 25, 2015

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