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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
  Purpose

In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to nasal CPAP, after surfactant is given. The primary outcome measure is the rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a) early, if the baby is unable to be placed back on CPAP (needs mechanical ventilation) or, b) late, if the baby requires retreatment with surfactant within 8 hours or more than 2 doses of surfactant.

The objective of this protocol is to reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by instilling surfactant though an LMA, while achieving comparable efficacy of surfactant treatment.

The hypothesis is that surfactant treatment through an LMA will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation, when compared with standard surfactant treatment following sedation and endotracheal intubation.


Condition Intervention Phase
Respiratory Distress Syndrome, Newborn Device: Endotracheal tube insertion Device: Laryngeal mask airway insertion Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rescue Surfactant for Respiratory Distress Syndrome (RDS) in Newborns: Comparing Efficacy of Delivery Via Laryngeal Mask Airway to Delivery by Endotracheal Intubation

Resource links provided by NLM:


Further study details as provided by Joaquim M.B. Pinheiro, Albany Medical College:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Number of Surfactant Doses [ Time Frame: 96 hr ]
  • Days on Assisted Ventilation [ Time Frame: 2 months ]
  • Days on Supplemental Oxygen [ Time Frame: 2 months ]
  • Rate of Pneumothorax [ Time Frame: 96 hrs ]
  • Rate of BPD (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age) [ Time Frame: 2 months ]
  • Complications During Insertion of LMA [ Time Frame: 96 hrs ]
  • Number of Intubation Episodes Per Patient [ Time Frame: 7 days ]
  • Mortality Rate [ Time Frame: 2 months ]

Enrollment: 61
Study Start Date: December 2009
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endotracheal intubation
Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication
Device: Endotracheal tube insertion
Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)
Experimental: Laryngeal mask airway
Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication
Device: Laryngeal mask airway insertion
Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Other Name: LMA North America

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild-to-moderate RDS
  • Postnatal age 4 to 48 hours
  • Gestational age 29 0/7 to 36 6/7 weeks
  • Treated with nasal CPAP ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours to maintain SpO2 88-95%
  • Informed consent

Exclusion Criteria:

  • Weight < 1000 g
  • Airway anomalies
  • Pulmonary air leaks
  • Craniofacial or cardiothoracic malformations
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042600


Locations
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
ONY
LMA North America, Inc.
Investigators
Principal Investigator: Joaquim M Pinheiro, MD, MPH Albany Medical College
Principal Investigator: Querube Santana, MD Albany Medical College
  More Information

Responsible Party: Joaquim M.B. Pinheiro, Professor of Pediatrics, 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
Last Verified: June 2014

Keywords provided by Joaquim M.B. Pinheiro, Albany Medical College:
Respiratory distress syndrome
Surfactant
Tracheal intubation
Laryngeal mask airway
Newborn

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Atropine
Pulmonary Surfactants
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action