Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Respiratory Distress Syndrome Clinical Trial

Official title:

Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116921
• Other study ID #: 1004M81177
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: July 7, 2015
• Start date: February 2011
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 36 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Nasal continuous positive airway pressure (nCPAP)
nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
• Laryngeal Mask Airway (LMA) to deliver surfactant
Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California
United States	University of Wisconsin- Madison	Madison	Wisconsin
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	University of California- San Diego Medical Center	San Diego	California
United States	St Paul Children's Hospital	St Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for intubation and mechanical ventilation in the first seven days of life.		Seven days	No
Secondary	Duration of CPAP therapy		During hospitalization	No
Secondary	Duration of oxygen therapy		During hospitalization	No
Secondary	Incidence of pulmonary airleaks		First 7 days of life	No
Secondary	Incidence of severe IVH or PVL		During hospitalization	No
Secondary	Incidence of Chronic Lung Disease		Measured at hospital discharge	No
Secondary	Time, number of attempts, and physiologic stability		During LMA or ETT placement	Yes