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Completed

NCT Number: NCT01116921

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.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Tract Diseases

Age range

Up to 36 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 surfactant

Device

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

Surfactants, Pulmonary

Drug

Curosurf®, Chiesi USA, Inc., Cary, NC

Primary outcomes

  1. 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 outcomes

  1. Duration of CPAP Therapy

    Time frame: During first seven days of life

  2. Duration of Oxygen Therapy

    Time frame: During first seven days of life

  3. Incidence of Pulmonary Airleaks

    Time frame: First 7 days of life

  4. Incidence of Severe IVH or PVL

    Time frame: During hospitalization

  5. Incidence of Chronic Lung Disease

    Time frame: Measured at hospital discharge

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 5, 2010
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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