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

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

sites

University of Wisconsin-Madison

Madison, Wisconsin 53706

(608) 263-2400