Trial record 4 of 19 for:
bronchopulmonary dysplasia OR neonatal chronic lung disease | Open Studies | NIH, U.S. Fed
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia (TOLSURF)
This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
Roberta Ballard, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01022580
First received: November 19, 2009
Last updated: May 22, 2013
Last verified: May 2013
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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:
MedlinePlus related topics:
Premature Babies
Drug Information available for:
Nitric oxide
U.S. FDA Resources
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 2014 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022580
Locations
| United States, Arkansas | |
| University of Arkansas - Arkansas Childrens Hospital | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: Sherry Courtney, MD SCourtney@uams.edu | |
| Principal Investigator: Sherry Courtney, MD | |
| United States, California | |
| Alta Bates Medical Center | Active, not recruiting |
| Berkeley, California, United States, 94705 | |
| Oakland Children's Hospital | Active, not recruiting |
| Oakland, California, United States, 94609 | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Roberta Keller, MD 415-514-3192 kellerr@peds.ucsf.edu | |
| Contact: Roberta A Ballard, MD 415-476-1888 ballardr@peds.ucsf.edu | |
| Principal Investigator: Roberta Keller, MD | |
| United States, Florida | |
| Wolfson Children's Hospital and Shands HospitaL | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Mark Hudak, MD 904-244-3508 mark.hudak@jax.ufl.edu | |
| Principal Investigator: Mark Hudak, MD | |
| Florida Hospital for Children | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact: Rajan Wadhawan, MD rajan.wadhawan.MD@flhosp.org | |
| All Children's Hospital | Recruiting |
| St Petersburg, Florida, United States, 33701 | |
| Contact: Victor McKay, MD victor.mcKay@allkids.org | |
| Principal Investigator: Victor McKay, MD | |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Nicolas Porta, MD n-porta@northwestern.edu | |
| Principal Investigator: Robin Steinhorn, MD | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Nicolas Porta 312-227-5366 n-porta@northwestern.edu | |
| Principal Investigator: Robin Steinhorn, MD | |
| United States, Minnesota | |
| University of Minnesota Medical School | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Catherine Bendel, MD 612-626-3250 bende001@umn.edu | |
| Principal Investigator: Catherine Bendel, MD | |
| Sub-Investigator: Michael Georgieff, MD | |
| Childrens Hospital and Clinics of Minnesota- Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Ellen Bendel-Stenzel, MD 612-813-6288 Ellen.Bendel-Stenzel@childrensmn.org | |
| Principal Investigator: Ellen Bendel-Stenzel, MD | |
| Children's Hospital and Clinics of Minnesota - St Paul | Recruiting |
| St Paul, Minnesota, United States, 55102 | |
| Contact: Andrea Lampland, MD 651-220-5736 alljmrh@aol.com | |
| Principal Investigator: Mark Mammel, MD | |
| Sub-Investigator: Andrea Lampland, MD | |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: William Truog, MD 816-234-3592 wtruog@cmh.edu | |
| Principal Investigator: William Truog, MD | |
| United States, New York | |
| Women's and Children's Hospital of Buffalo | Active, not recruiting |
| Buffalo, New York, United States, 14222 | |
| Stony Brook University Medical Center | Active, not recruiting |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Wake Forest University- Forsyth Hospital and Brenner Hospital | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Jennifer Helderman, MD jhelderm@wakehealth.edu | |
| Principal Investigator: Jennifer Helderman, MD | |
| Sub-Investigator: Michael O'Shea, MD | |
| United States, South Carolina | |
| Medical University of South Carolina(MUSC) | Recruiting |
| Charleston, South Carolina, United States, 29403 | |
| Contact: Frances R Koch, MD 843-792-8903 kochf@musc.edu | |
| Sub-Investigator: Carol Wagner, MD | |
| Principal Investigator: Frances R Koch, MD | |
| United States, Tennessee | |
| UT Memphis- Memphis Medical Center | Recruiting |
| Memphis, Tennessee, United States, 38103-2807 | |
| Contact: Reddy Dhanireddy, MD 901-448-4750 rdhanire@uthsc.edu | |
| Principal Investigator: Reddy Dhanireddy, MD | |
| United States, Texas | |
| Texas Children's Hospital | Suspended |
| Houston, Texas, United States, 77030 | |
| UT Houston Health Science Center | Recruiting |
| Houston, Texas, United States, 77030-1503 | |
| Contact: Eric Eichenwald, MD 713-500-5209 Eric.C.Eichenwald@uth.tmc.edu | |
| Principal Investigator: Eric Eichenwald, MD | |
| United States, Washington | |
| University of Washington, Seattle | Recruiting |
| Seattle, Washington, United States, 98195-6320 | |
| Contact: Dennis Mayock, M.D. 206-543-5257 mayock@u.washington.edu | |
| Principal Investigator: Dennis Mayock, MD | |
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: | May 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Francisco:
|
bronchopulmonary dysplasia neonates pulmonary outcome lung function Bronchopulmonary Dysplasia nitric oxide surfactant |
BPD prematurity iNO neurodevelopmental outcome Infasurf Surfactant Dysfunction |
Additional relevant MeSH terms:
|
Bronchopulmonary Dysplasia Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Pulmonary Surfactants Hyperplasia Pathologic Processes Nitric Oxide Calfactant 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 Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013