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comparing methods of post-delivery stabilization

Study News

Status
The DR Management study (DRM) was structured in three phases. The first phase began in February 2003 and was the demonstration of technical competency using nasal CPAP. The second phase began in August 2003 and was a feasibility study. Centers followed the protocol for a period of ten months and randomly assigned infants to one of the three interventions. With the success of the first two phases, the third phase began in May 2004 and ran through March 2009. There were 658 babies enrolled in this trial. The results of this study were presented at the Annual Meeting of Vermont Oxford Network in December 2009 and the Society for Pediatric Research in May 2010. The manuscript was published in the November 2011 issue of Pediatrics. (citation below)

Study Purpose
The purpose of the Delivery Room Management Trial was to compare the effect of three distinct methods of post-delivery stabilization and subsequent respiratory care on chronic lung disease and survival in premature infants at high risk of respiratory distress syndrome.

The three approaches to post-delivery care include:

  1. Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
  2. Early stabilization on Nasal Continuous positive Airway Pressure (NCPAP) with selective intubation and surfactant administration for clinical indications, and
  3. Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to NCPAP.

Study Design
The Delivery Room Management Trial was a multicenter randomized trial in 34 neonatal intensive care units of the Vermont Oxford Network.

Publications
Dunn MS, Kaempf J, de Klerk A, de Klerk R, Reilly M, Howard D, Ferrelli K, O'Conor J, Soll RF; for the 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-e1076. Epub 2011 Oct 24.

Steering Committee
Jeanette M. Conner, MS, Ph.D. Maya Center for Integrated Medicine & Research
Alan de Klerk, MBChSB, Maimonides Medical Center
Rose de Klerk, RNC, New York Presbyterian Hospital
Michael S. Dunn, MD, FRCPC, Sunnybrook & Women's College, Co-Principal Investigator
Joseph W. Kaempf, MD, Providence St. Vincent Medical Center
Maureen C. Reilly, RRT, RRCP, Sunnybrook & Women's College
Roger F. Soll, MD, University of Vermont College of Medicine, Co-Principal Investigator

Consultants
Jen Tien-Wung, MD, Columbia Presbyterian Medical Center

Please contact the VON Clinical Trials Staff for additional information.


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