Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Other study identifiers
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)Brief Summary
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 Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 648 participants
- Study completion date
June 2011
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
August 2003
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
October 24, 2005
Actual (reported)First Posted
October 25, 2005
Actual (reported)Primary Completion
June 2009
Actual (reported)Study Completion
June 2011
Actual (reported)Results Posted
September 14, 2012
Actual (reported)
- Last Updated
- January 18, 2023
- Status Verified
- November 2022
- Results QC Date
- August 16, 2012
- Last Update Submitted
- January 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Death or Chronic Lung Disease
at 36 weeks postmenstrual age
Death
36 weeks adjusted age
Study Arms (3)
PS Group
ACTIVE COMPARATORIntubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
NCPAP Group
EXPERIMENTALEarly stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
ISX Group
EXPERIMENTALIntubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Interventions
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
You may qualify if:
- Imminent delivery
- No potentially life-threatening congenital anomaly or genetic syndrome
- No known lung maturity
- Antenatal steroid status known
- Written, informed consent obtained (on admission or prior to delivery).
You may not qualify if:
- Stillborn (Apgar score of 0 at one minute of age)
- Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vermont Oxford NetworkResearch networklead
Study Sites (1)
Vermont Oxford Network
Burlington, Vermont, 05401, United States
Related Publications (1)
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.
PMID: 22025591RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Roger F. Soll, MD
- Organization
- Vermont Oxford Network
Study Officials
- PRINCIPAL INVESTIGATOR
Roger F Soll, MD
Vermont Oxford Network
- PRINCIPAL INVESTIGATOR
Michael Dunn, MD
Sunnybrook and Women's Hospital, Toronto, Ontario, Canada
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Enrollment
648 participants (actual enrollment reported by the registry).
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
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.
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
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
- Registry identifier
- NCT00244101
- Data provider
- ClinicalTrials.gov
- Source updated
- 2023-01-18
- Normalization version
- ctgov-legacy-1
Source retrieved: