Sponsor study identifier
interventional
648
1 country
1
Study Start
August 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
June 2011
Actual (reported)The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2003
Date type not reportedThis date has not been verified as actual or estimated.
October 24, 2005
Actual (reported)October 25, 2005
Actual (reported)June 2009
Actual (reported)June 2011
Actual (reported)September 14, 2012
Actual (reported)Death or Chronic Lung Disease
at 36 weeks postmenstrual age
Death
36 weeks adjusted age
Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
Vermont Oxford Network
Burlington, Vermont, 05401, United States
Dunn MS, Kaempf J, de Klerk A, de Klerk R, Reilly M, Howard D, Ferrelli K, O'Conor J, Soll RF; Vermont Oxford Network DRM Study Group. Randomized trial comparing 3 approaches to the initial respiratory management of preterm neonates. Pediatrics. 2011 Nov;128(5):e1069-76. doi: 10.1542/peds.2010-3848. Epub 2011 Oct 24.
The study was stopped after recruitment reached 74% of the projected sample size because of difficulties with enrollment. Because this study could not be blinded, there was a possibility of bias influencing the outcomes if providers managing the infants did not follow strict guidelines.
Roger F Soll, MD
Vermont Oxford Network
Michael Dunn, MD
Sunnybrook and Women's Hospital, Toronto, Ontario, Canada
648 participants (actual enrollment reported by the registry).
First Submitted
October 24, 2005
First Posted
October 25, 2005
Study Start
August 2003
Date type not reportedThis date has not been verified as actual or estimated.
Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2009
Actual (reported)Study Completion
June 2011
Actual (reported)Last Updated
January 18, 2023
Results First Posted
September 14, 2012
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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