Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia (TOLSURF)
|ClinicalTrials.gov Identifier: NCT01022580|
Recruitment Status : Unknown
Verified September 2013 by Roberta Ballard, University of California, San Francisco.
Recruitment status was: Active, not recruiting
First Posted : December 1, 2009
Last Update Posted : September 24, 2013
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roberta Ballard, University of California, San Francisco
Results Submitted - Not Posted on ClinicalTrials.gov
Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
|Recruitment Status :||Unknown|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||July 2015|
|Submission Cycle||Results Submitted to ClinicalTrials.gov||Results Returned after Quality Control Review|
|1||August 26, 2015||September 25, 2015|
|2||October 9, 2015||November 6, 2015|
|3||December 3, 2015||January 7, 2016|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
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;168:23-9.e4. doi: 10.1016/j.jpeds.2015.09.031. Epub 2015 Oct 21.