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Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042600
First Posted: January 5, 2010
Last Update Posted: July 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
ONY
LMA North America, Inc.
Information provided by (Responsible Party):
Joaquim M.B. Pinheiro, Albany Medical College
Results First Submitted: June 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Respiratory Distress Syndrome, Newborn
Interventions: Device: Endotracheal tube insertion
Device: Laryngeal mask airway insertion

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant excluded and removed from study after randomization due to ineligibility (pre-existing pneumothorax)

Reporting Groups
  Description
Endotracheal Intubation

Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication

Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)

Laryngeal Mask Airway

Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication

Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)


Participant Flow:   Overall Study
    Endotracheal Intubation   Laryngeal Mask Airway
STARTED   31   30 
COMPLETED   30   30 
NOT COMPLETED   1   0 
Ineligible                1                0 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of Surfactant Within 8 Hours, or Needing More Than 2 Doses of Surfactant).   [ Time Frame: 96 hours ]

2.  Secondary:   Mortality Rate   [ Time Frame: 2 months ]

3.  Secondary:   Number of Surfactant Doses   [ Time Frame: 96 hr ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Days on Assisted Ventilation   [ Time Frame: 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Days on Supplemental Oxygen   [ Time Frame: 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Rate of Pneumothorax   [ Time Frame: 96 hrs ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Rate of BPD (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age)   [ Time Frame: 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Complications During Insertion of LMA   [ Time Frame: 96 hrs ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Number of Intubation Episodes Per Patient   [ Time Frame: 7 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  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.


Results Point of Contact:  
Name/Title: Joaquim Pinheiro, MD, MPH
Organization: Albany Medical Center
phone: 518-262-5421
e-mail: pinheij@mail.amc.edu



Responsible Party: Joaquim M.B. Pinheiro, Albany Medical College
ClinicalTrials.gov Identifier: NCT01042600     History of Changes
Other Study ID Numbers: 2599
First Submitted: January 4, 2010
First Posted: January 5, 2010
Results First Submitted: June 16, 2014
Results First Posted: July 16, 2014
Last Update Posted: July 16, 2014