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

This study has been completed.
Sponsor:
Collaborators:
ONY
LMA North America, Inc.
Information provided by (Responsible Party):
Joaquim M.B. Pinheiro, Albany Medical College
ClinicalTrials.gov Identifier:
NCT01042600
First received: January 4, 2010
Last updated: June 16, 2014
Last verified: June 2014
Results First Received: June 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Respiratory Distress Syndrome, Newborn
Interventions: Device: Endotracheal tube insertion
Device: Laryngeal mask airway insertion

  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
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Single ineligible patient excluded in the endotracheal intubation group

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)

Total Total of all reporting groups

Baseline Measures
    Endotracheal Intubation     Laryngeal Mask Airway     Total  
Number of Participants  
[units: participants]
  31     30     61  
Age, Customized  
[units: participants]
     
Gestational age <33 weeks     18     11     29  
Gestational age >=33 weeks     13     19     32  
Gender  
[units: participants]
     
Female     13     9     22  
Male     18     21     39  



  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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Days on Assisted Ventilation   [ Time Frame: 2 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Days on Supplemental Oxygen   [ Time Frame: 2 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Rate of Pneumothorax   [ Time Frame: 96 hrs ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Complications During Insertion of LMA   [ Time Frame: 96 hrs ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  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


No publications provided


Responsible Party: Joaquim M.B. Pinheiro, Albany Medical College
ClinicalTrials.gov Identifier: NCT01042600     History of Changes
Other Study ID Numbers: 2599
Study First Received: January 4, 2010
Results First Received: June 16, 2014
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board