Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)
Stopped early · Not applicable
Conditions studied: Respiratory Distress Syndrome, Newborn
In brief
In this protocol we will conduct a randomized controlled trial where babies with respiratory distress syndrome (RDS) who have not yet reached criteria for intubation, will be randomized to receive surfactant by LMA or to continue receiving standard therapy of nasal CPAP and supplemental oxygen. All babies will be given surfactant by endotracheal tube if they reach "failure" criteria, which is the standard criterion for surfactant administration (i.e., FiO2= 65% while receiving nasal CPAP). The objective of this RCT is to determine if surfactant can be successfully administered by LMA, thus perhaps avoiding the need for endotracheal intubation. The hypothesis is that fewer babies in the LMA group would reach failure criteria.
Key facts
- Study ID
- NCT00599651
- Run by
- University of Virginia
- People needed
- 380
- Starts
- 2005-06-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2010-05-07
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Birthweight > 1200 grams
- Chronologic age < 72 hours.
- Diagnosis of RDS by clinical and radiographic criteria.
- Treated with nasal CPAP and supplemental oxygen > 30% and not requiring > 60% FiO2 for longer than 30 minutes to maintain SaO2 88-95%.
- Parental consent.
You may not qualify if…
- Birthweight < 1200 gms.
- Diagnosis other than RDS (e.g., meconium aspiration syndrome).
- Babies who require or have already had endotracheal intubation.
- Babies with congenital anomalies or conditions thought by the attending physician to contribute to respiratory symptoms and/or to restrict adequate spontaneous breathing (e.g., congenital heart disease, obtundation from maternal drugs, certain airway malformations, diaphragmatic hernia).
Where it is running
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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