Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
NCT ID: NCT01022580
Last Updated: 2021-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
511 participants
INTERVENTIONAL
2010-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
Infasurf surfactant (ONY, Inc.)
Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Sham (No Treatment)
Infants already receiving inhaled nitric oxide will receive "Sham (no treatment)" doses on study days 0,2,4,6, and 8.
Sham (No Treatment)
Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Interventions
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Infasurf surfactant (ONY, Inc.)
Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Sham (No Treatment)
Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Day of life 7-14
* Intubated and mechanically ventilated
* Plan to treat with inhaled nitric oxide
Exclusion Criteria
* 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
7 Days
14 Days
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Roberta Ballard
OTHER
Responsible Party
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Roberta Ballard
Professor of Pediatrics
Principal Investigators
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Roberta A Ballard, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of Arkansas - Arkansas Childrens Hospital
Little Rock, Arkansas, United States
Alta Bates Medical Center
Berkeley, California, United States
Oakland Children's Hospital
Oakland, California, United States
University of California, San Francisco
San Francisco, California, United States
Wolfson Children's Hospital and Shands HospitaL
Jacksonville, Florida, United States
Florida Hospital for Children
Orlando, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Childrens Hospital and Clinics of Minnesota- Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Children's Hospital and Clinics of Minnesota - St Paul
Saint Paul, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Women's and Children's Hospital of Buffalo
Buffalo, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Wake Forest University- Forsyth Hospital and Brenner Hospital
Winston-Salem, North Carolina, United States
Medical University of South Carolina(MUSC)
Charleston, South Carolina, United States
UT Memphis- Memphis Medical Center
Memphis, Tennessee, United States
UT Houston Health Science Center
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Washington, Seattle
Seattle, Washington, United States
Countries
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References
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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. doi: 10.1056/NEJMoa061088.
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. doi: 10.1542/peds.2007-0095.
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. doi: 10.1542/peds.2006-2683.
Ballard RA, Keller RL, Black DM, Ballard PL, Merrill JD, Eichenwald EC, Truog WE, Mammel MC, Steinhorn RH, Rogers EE, Ryan RM, Durand DJ, Asselin JM, Bendel CM, Bendel-Stenzel EM, Courtney SE, Dhanireddy R, Hudak ML, Koch FR, Mayock DE, McKay VJ, O'Shea TM, Porta NF, Wadhawan R, Palermo L; TOLSURF Study Group. Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide. J Pediatr. 2016 Jan;168:23-29.e4. doi: 10.1016/j.jpeds.2015.09.031. Epub 2015 Oct 21.
Wai KC, Hibbs AM, Steurer MA, Black DM, Asselin JM, Eichenwald EC, Ballard PL, Ballard RA, Keller RL; Trial of Late Surfactant (TOLSURF) Study Group. Maternal Black Race and Persistent Wheezing Illness in Former Extremely Low Gestational Age Newborns: Secondary Analysis of a Randomized Trial. J Pediatr. 2018 Jul;198:201-208.e3. doi: 10.1016/j.jpeds.2018.02.032. Epub 2018 Apr 4.
Keller RL, Eichenwald EC, Hibbs AM, Rogers EE, Wai KC, Black DM, Ballard PL, Asselin JM, Truog WE, Merrill JD, Mammel MC, Steinhorn RH, Ryan RM, Durand DJ, Bendel CM, Bendel-Stenzel EM, Courtney SE, Dhanireddy R, Hudak ML, Koch FR, Mayock DE, McKay VJ, Helderman J, Porta NF, Wadhawan R, Palermo L, Ballard RA; TOLSURF Study Group. The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1-Year Corrected Age. J Pediatr. 2017 Apr;183:19-25.e2. doi: 10.1016/j.jpeds.2016.12.059. Epub 2017 Jan 16.
Wai KC, Keller RL, Lusk LA, Ballard RA, Chan DK; Trial of Late Surfactant (TOLSURF) Study Group. Characteristics of Extremely Low Gestational Age Newborns Undergoing Tracheotomy: A Secondary Analysis of the Trial of Late Surfactant Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Jan 1;143(1):13-19. doi: 10.1001/jamaoto.2016.2428.
Other Identifiers
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H10842-33541-01A
Identifier Type: -
Identifier Source: org_study_id
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