Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Device: Nasal continuous positive airway pressure (nCPAP); Device: Laryngeal Mask Airway (LMA) to deliver surfactant; Drug: Surfactants, Pulmonary

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University Medical Center
    • San Diego, California, United States, 92103
      • University of California- San Diego Medical Center
  • Minnesota
    • Maple Grove, Minnesota, United States, 55369
      • Maple Grove Hospital
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Children's Hospital
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Hospital
    • St Paul, Minnesota, United States, 55102
      • St Paul Children's Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • University of Wisconsin- Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.	"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.	Seven days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• 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

Publications and helpful links

General Publications

• Roberts KD, Brown R, Lampland AL, Leone TA, Rudser KD, Finer NN, Rich WD, Merritt TA, Czynski AJ, Kessel JM, Tipnis SM, Stepka EC, Mammel MC. Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial. J Pediatr. 2018 Feb;193:40-46.e1. doi: 10.1016/j.jpeds.2017.09.068. Epub 2017 Nov 22.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimate): May 5, 2010

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: January 6, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: neonate; respiratory distress syndrome; surfactant; laryngeal mask airway
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: 1004M81177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO