Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
Completed · Not applicable
Conditions studied: Respiratory Distress Syndrome
In brief
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.
Key facts
- Study ID
- NCT01116921
- Run by
- University of Minnesota
- People needed
- 103
- Starts
- 2011-02-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2017-02-27
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- North Memorial Hospital — Robbinsdale, Minnesota, United States
- St Paul Children's Hospital — Saint Paul, Minnesota, United States
- University of Wisconsin- Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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