CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 103 enrolled
Drug / intervention
Surfactants, Pulmonary +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01116921
NCT01116921N/ACompleted
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Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

University of Minnesota·interventional·Posted May 5, 2010·Updated Feb 27, 2017

In Brief

A clinical study evaluating Nasal continuous positive airway pressure (nCPAP), Laryngeal Mask Airway (LMA) to deliver surfactant, and 1 other intervention for Respiratory Distress Syndrome. Completed, enrolled 103 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Distress Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 5, 2010
Enrollment StartFeb 1, 2011
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.2 years ago

Interventions

Nasal continuous positive airway pressure (nCPAP)device

nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.

Laryngeal Mask Airway (LMA) to deliver surfactantdevice

Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)

Surfactants, Pulmonarydrug

Curosurf®, Chiesi USA, Inc., Cary, NC