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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.
Secondary outcomes were total number of hours on mechanical ventilation, CPAP and supplemental oxygen during the first 7 days of life and for the entire hospitalization. Other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks PMA), oxygen requirement at discharge, severe intraventricular hemorrhage (Grade 3/4), and periventricular leukomalacia.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Loma Linda University Medical Center
Loma Linda, California, United States
University of California- San Diego Medical Center
San Diego, California, 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
St Paul Children's Hospital
Saint Paul, Minnesota, United States
University of Wisconsin- Madison
Madison, Wisconsin, United States
Start Date
February 1, 2011
Primary Completion Date
April 1, 2015
Completion Date
April 1, 2015
Last Updated
February 27, 2017
103
ACTUAL participants
Nasal continuous positive airway pressure (nCPAP)
DEVICE
Laryngeal Mask Airway (LMA) to deliver surfactant
DEVICE
Surfactants, Pulmonary
DRUG
Lead Sponsor
University of Minnesota
NCT07450846
NCT07414056
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06701669