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Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vermont Oxford Network
ClinicalTrials.gov Identifier:
NCT00244101
First received: October 24, 2005
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
Results First Received: August 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Respiratory Distress Syndrome, Newborn
Interventions: Drug: PS Group
Device: NCPAP Group
Drug: ISX Group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PS Group Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
NCPAP Group Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
ISX Group Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.

Participant Flow:   Overall Study
    PS Group     NCPAP Group     ISX Group  
STARTED     209     223     216  
COMPLETED     209     223     216  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
PS Group Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
NCPAP Group Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
ISX Group Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Total Total of all reporting groups

Baseline Measures
    PS Group     NCPAP Group     ISX Group     Total  
Number of Participants  
[units: participants]
 		  209     223     216     648  
Age  
[units: participants]
 		       
<=18 years     209     223     216     648  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  28.0  ± 1.1     28.1  ± 1.3     28.1  ± 1.1     28.0  ± 1.1  
Gender  
[units: participants]
 		       
Female     118     99     115     332  
Male     91     124     101     316  
Region of Enrollment  
[units: participants]
 		       
United States     209     223     216     648  



  Outcome Measures

1.  Primary:   Death or Chronic Lung Disease   [ Time Frame: at 36 weeks postmenstrual age ]
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2.  Primary:   Death   [ Time Frame: 36 weeks adjusted age ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Complications of Prematurity   [ Time Frame: prior to hospital discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Days of Ventilator Support   [ Time Frame: prior to hospital discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Days in Hospital   [ Time Frame: prior to hospital discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Parental Questionnaire for Health Status   [ Time Frame: at 24 months of age ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Roger F. Soll, MD
Organization: Vermont Oxford Network
phone: 802 865 4814 ext 212
e-mail: roger.soll@vtmednet.org


No publications provided by Vermont Oxford Network

Publications automatically indexed to this study:


Responsible Party: Vermont Oxford Network
ClinicalTrials.gov Identifier: NCT00244101     History of Changes
Other Study ID Numbers: CHRMS 03-233
Study First Received: October 24, 2005
Results First Received: August 16, 2012
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board