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Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

This study has been completed.
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: January 6, 2017
Last verified: January 2017
  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 Drug: Surfactants, Pulmonary

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]
    "Treatment Failure" criteria were the same for both groups. "Treatment Failure" required two of the following: 1) FiO2 >40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 >65mmHg on ABG/CBG or >70 on VBG, or 3) pH<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 >40%, or 4) deemed necessary by medical provider.


Secondary Outcome Measures:
  • Duration of CPAP Therapy [ Time Frame: During first seven days of life ]
  • Duration of Oxygen Therapy [ Time Frame: During first seven days of life ]
  • Incidence of Pulmonary Airleaks [ Time Frame: First 7 days of life ]
  • Incidence of Severe IVH or PVL [ Time Frame: During hospitalization ]
  • Incidence of Chronic Lung Disease [ Time Frame: Measured at hospital discharge ]

Enrollment: 103
Study Start Date: February 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nCPAP Control Group
Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered.
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
Once proper placement of the LMA was achieved, surfactant (Curosurf®, 2.5 ml/kg, Chiesi USA, Inc., Cary, NC) was administered. The LMA cuff was then deflated, LMA removed and the infant placed back on nasal CPAP 6 cm H2O.
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)
Drug: Surfactants, Pulmonary
Curosurf®, Chiesi USA, Inc., Cary, NC

Detailed Description:
Secondary outcomes were total number of hours on mechanical ventilation, CPAP and supplemental oxygen during the first 7 days of life and for the entire hospitalization. Other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks PMA), oxygen requirement at discharge, severe intraventricular hemorrhage (Grade 3/4), and periventricular leukomalacia.
  Eligibility

Ages Eligible for Study:   up to 36 Hours   (Child)
Sexes Eligible for Study:   All
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

Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92350
University of California- San Diego Medical Center
San Diego, California, United States, 92103
United States, Minnesota
Maple Grove Hospital
Maple Grove, Minnesota, United States, 55369
University of Minnesota Children's Hospital
Minneapolis, Minnesota, United States, 55455
North Memorial Hospital
Robbinsdale, Minnesota, United States, 55422
St Paul Children's Hospital
St Paul, Minnesota, United States, 55102
United States, Wisconsin
University of Wisconsin- Madison
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Study Chair: Kari D Roberts, M.D. University of Minnesota Masonic 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
Principal Investigator: Erin Stepka, M.D. Maple Grove Hospital and North Memorial Hospital
Principal Investigator: Julie Kessel, M.D. University of Wisconsin, Madison
  More Information

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
Results First Received: January 6, 2017
Last Updated: January 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on July 21, 2017