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Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

NCT01116921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2017-02-27

Study results available
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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.

Conditions

  • Respiratory Distress Syndrome

Interventions

DEVICE

Nasal continuous positive airway pressure (nCPAP)

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

DEVICE

Laryngeal Mask Airway (LMA) to deliver surfactant

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

DRUG

Surfactants, Pulmonary

Curosurf®, Chiesi USA, Inc., Cary, NC

Sponsors & Collaborators

Principal Investigators

  • Kari D Roberts, M.D. · University of Minnesota Masonic Children's Hospital

  • Sijani Tipnis, M.D. · University of California, San Diego

  • Andrea L Lampland, M.D. · St Paul Children's Hospital

  • Allen Merritt, M.D. · Loma Linda University

  • Erin Stepka, M.D. · Maple Grove Hospital and North Memorial Hospital

  • Julie Kessel, M.D. · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
36 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116921 on ClinicalTrials.gov