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

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ClinicalTrials.gov Identifier: NCT00569530

Recruitment Status : Completed

First Posted : December 7, 2007

Results First Posted : June 28, 2016

Last Update Posted : June 28, 2016

Sponsor:

Collaborators:

Mallinckrodt

ONY

Information provided by (Responsible Party):

Roberta L. Keller, University of California, San Francisco

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) Bronchopulmonary Dysplasia	Drug: Infasurf (ONY Inc.) Drug: Sham	Phase 3

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	85 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	January 2008
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Surfactant dysfunction

Drug Information available for: Nitric oxide Calfactant

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome Bronchopulmonary Dysplasia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

SP-B Content [ Time Frame: One day after dose ]
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 ]
Alive without need for oxygen at 36 weeks post menstrual age.

Eligibility Criteria

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Ages Eligible for Study:	up to 14 Days (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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.

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 ( Other Identifier: FDA )
First Posted:	December 7, 2007 Key Record Dates
Results First Posted:	June 28, 2016
Last Update Posted:	June 28, 2016
Last Verified:	May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Roberta L. Keller, 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

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