Clinical Trial: Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of Rescue Surfactant Delivery Via Endotracheal Intubation (INSURE Technique) Versus Laryngeal Mask Airway (LMA) for Respiratory Distress Syndrome (RDS) in Preterm

Brief Summary:

In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway (inserted after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a) early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal intubation and mechanical ventilation) or, b) late, if the baby requires ventilation, retreatment with surfactant within 8 hours or more than 2 doses of surfactant.

The objective of this protocol is to reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by instilling surfactant though an LMA, while achieving comparable efficacy of surfactant treatment.

The hypothesis is that surfactant treatment through an LMA will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation, when compared to standard surfactant treatment following endotracheal intubation with sedation.


Detailed Summary:

Respiratory Distress Syndrome (RDS) due to deficiency of pulmonary surfactant is common in preterm newborns. Early treatment with surfactant improves oxygenation, reduces the need for subsequent mechanical ventilation, decreases the incidence of pulmonary air leaks and chronic lung disease and it also reduces mortality in extremely premature newborns. Optimal treatment of RDS includes surfactant therapy and avoidance of invasive mechanical ventilation by using nasal continuous positive airway pressure modes (NCPAP or NIPPV). The current standard method of surfactant delivery requires tracheal intubation and at least brief positive-pressure ventilation, as in the INSURE (Intubation-Surfactant-Extubation) approach. Because tracheal intubation causes pain and vagal-mediated physiologic instability in neonates, premedication with atropine and a narcotic is recommended. However, narcotic premedication increases respiratory depression, which may require sustained mechanical ventilation, thus contributing to the failure of INSURE. In a recent trial at our center, standard pretreatment with morphine and atropine was associated with failure of INSURE in more than 2/3 of patients. Consequently, we have recently changed our standard premedication for INSURE to the combination of atropine and remifentanil (a rapid onset, short-acting narcotic). The Laryngeal Mask Airway (LMA) is a commercially available, less invasive artificial airway that does not need to be inserted into the trachea; it is FDA-approved for use in neonates; preliminary data suggest that it can be used for surfactant administration, which in our trial was associated with a lower failure rate than the morphine plus INSURE approach.

The main objective of this study protocol is reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with mild to moderate RDS needing rescue surfactant
Sponsor: Albany Medical College

Current Primary Outcome: Avoidance of invasive mechanical ventilation [ Time Frame: 120 hours ]

Rate of success of success of surfactant therapy in avoiding invasive mechanical ventilation or clinically equivalent outcomes (FiO2 > 0.60 to maintain target SpO2, second dose of surfactant within 8 hours, or more than 2 total doses of surfactant)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of surfactant doses [ Time Frame: 120 hours ]
  • Days on any respiratory support [ Time Frame: 3 months ]
  • Rate of Pneumothorax [ Time Frame: 120 hours ]
  • Rate of bronchopulmonary dysplasia (O2 dependence at the later of 28 days of age or 36 weeks postmenstrual age) [ Time Frame: 3 months ]
  • Complications during insertion of LMA or endotracheal tube [ Time Frame: 120 hours ]
  • Mortality rate [ Time Frame: 3 months ]
    Mortality prior to hospital discharge


Original Secondary Outcome:

  • Number of surfactant doses [ Time Frame: 120 ]
  • Days on any respiratory support [ Time Frame: 3 months ]
  • Rate of Pneumothorax [ Time Frame: 120 hours ]
  • Rate of bronchopulmonary dysplasia (O2 dependence at the later of 28 days of age or 36 weeks postmenstrual age) [ Time Frame: 3 months ]
  • Complications during insertion of LMA or endotracheal tube [ Time Frame: 120 hours ]
  • Mortality rate [ Time Frame: 3 months ]
    Mortality prior to hospital discharge


Information By: Albany Medical College

Dates:
Date Received: June 13, 2014
Date Started: June 2014
Date Completion: August 2017
Last Updated: December 30, 2015
Last Verified: December 2015