Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

University of Minnesota103 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Respiratory Distress Syndrome

Interventions

Nasal continuous positive airway pressure (nCPAP)DEVICE

nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.

Laryngeal Mask Airway (LMA) to deliver surfactantDEVICE

Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)

Surfactants, PulmonaryDRUG

Curosurf®, Chiesi USA, Inc., Cary, NC

Eligibility

Sex: ALLMax age: 36 Hours

Medical Language ↔ Plain English

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

Locations (7)

Loma Linda University Medical Center

Loma Linda, California, United States

University of California- San Diego Medical Center

San Diego, California, United States

Maple Grove Hospital

Maple Grove, Minnesota, United States

University of Minnesota Children's Hospital

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Seven days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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