Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation
Completed · Phase 4
Conditions studied: Respiratory Distress Syndrome, Newborn
In brief
In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to nasal CPAP, 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 CPAP (needs mechanical ventilation) or, b) late, if the baby requires 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 with standard surfactant treatment following sedation and endotracheal intubation.
Key facts
- Study ID
- NCT01042600
- Run by
- Albany Medical College
- People needed
- 61
- Starts
- 2009-12-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2019-07-26
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Mild-to-moderate RDS
- Postnatal age 4 to 48 hours
- Gestational age 29 0/7 to 36 6/7 weeks
- Treated with nasal CPAP ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours to maintain SpO2 88-95%
- Informed consent
You may not qualify if…
- Weight < 1000 g
- Airway anomalies
- Pulmonary air leaks
- Craniofacial or cardiothoracic malformations
Where it is running
- Albany Medical Center — Albany, New York, United States
Full record on ClinicalTrials.gov
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