Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01116921
First received: May 3, 2010
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.


Condition Intervention
Respiratory Distress Syndrome
Device: Nasal continuous positive airway pressure (nCPAP)
Device: Laryngeal Mask Airway (LMA) to deliver surfactant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Need for intubation and mechanical ventilation in the first seven days of life. [ Time Frame: Seven days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of CPAP therapy [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]
  • Duration of oxygen therapy [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]
  • Incidence of pulmonary airleaks [ Time Frame: First 7 days of life ] [ Designated as safety issue: No ]
  • Incidence of severe IVH or PVL [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]
  • Incidence of Chronic Lung Disease [ Time Frame: Measured at hospital discharge ] [ Designated as safety issue: No ]
  • Time, number of attempts, and physiologic stability [ Time Frame: During LMA or ETT placement ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 144
Study Start Date: February 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nCPAP Control Group Device: Nasal continuous positive airway pressure (nCPAP)
nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Experimental: LMA Group Device: Nasal continuous positive airway pressure (nCPAP)
nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Device: Laryngeal Mask Airway (LMA) to deliver surfactant
Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)

  Eligibility

Ages Eligible for Study:   up to 36 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age at time of enrollment 28 0/7 to 35 6/7 weeks postmenstrual age
  • Age less than or equal to 36 hours old
  • On nCPAP 6 with supplemental oxygen requirement (Fi02 greater than or equal to 30%) for greater than or equal to 30 minutes (to maintain Sa02 between 88-92%)
  • Chest radiograph and clinical presentation consistent with respiratory distress syndrome (tachypnea, retractions, nasal flaring, and/or grunting

Exclusion Criteria:

  • Prior mechanical ventilation or surfactant administration
  • Major congenital anomaly
  • Abnormality of the airway
  • Respiratory distress secondary to an etiology other than respiratory distress syndrome (pneumothorax, meconium aspiration syndrome, pneumonia, hypoxic-ischemic encephalopathy)
  • Apgar score < 5 at 5 minutes of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116921

Contacts
Contact: Kari D Roberts, M.D. 612-625-9577 rober694@umn.edu

Locations
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92350
Contact: Allen Merritt, M.D.    909-558-7448      
Principal Investigator: Allen Merritt, M.D.         
University of California- San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Sijani Tipnis, M.D.    619-471-0209      
Principal Investigator: Sijani Tipnis, M.D.         
Sub-Investigator: Wade Rich, BSHS, RRT, CCRC         
United States, Minnesota
University of Minnesota Amplatz Children's Hospital Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kari D Roberts, M.D.    612-625-9577    rober694@umn.edu   
Principal Investigator: Kari D Roberts, M.D.         
St Paul Children's Hospital Recruiting
St Paul, Minnesota, United States, 55102
Contact: Andrea L Lampland, M.D.    651-220-5736      
Principal Investigator: Andrea L Lampland, M.D.         
Sub-Investigator: Mark C Mammel, M.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Study Chair: Kari D Roberts, M.D. University of Minnesota Amplatz Children's Hospital
Principal Investigator: Sijani Tipnis, M.D. University of California, San Diego
Principal Investigator: Andrea L Lampland, M.D. St Paul Children's Hospital
Principal Investigator: Allen Merritt, M.D. Loma Linda University
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01116921     History of Changes
Other Study ID Numbers: 1004M81177
Study First Received: May 3, 2010
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
neonatal respiratory distress syndrome
surfactant
laryngeal mask airway

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014