Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates



Status:Completed
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:February 2011
End Date:April 2015

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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.


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
We found this trial at
7
sites
Robbinsdale, Minnesota
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Robbinsdale, MN
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Loma Linda, CA
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Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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Madison, WI
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Maple Grove, Minnesota 55369
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Maple Grove, MN
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Minneapolis, MN
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San Diego, CA
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St Paul, Minnesota 55102
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St Paul, MN
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