Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)
This study has been terminated.
(Study was closed due to extremely low enrollment)
Sponsor:
University of Virginia
Collaborators:
LMA North America
ONY
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00599651
First received: December 29, 2007
Last updated: May 6, 2010
Last verified: May 2010
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Purpose
In this protocol we will conduct a randomized controlled trial where babies with respiratory distress syndrome (RDS) who have not yet reached criteria for intubation, will be randomized to receive surfactant by LMA or to continue receiving standard therapy of nasal CPAP and supplemental oxygen. All babies will be given surfactant by endotracheal tube if they reach "failure" criteria, which is the standard criterion for surfactant administration (i.e., FiO2= 65% while receiving nasal CPAP).
The objective of this RCT is to determine if surfactant can be successfully administered by LMA, thus perhaps avoiding the need for endotracheal intubation. The hypothesis is that fewer babies in the LMA group would reach failure criteria.
| Condition | Intervention |
|---|---|
|
Respiratory Distress Syndrome, Newborn |
Device: Surfactant administered via Laryngeal Mask Airway (LMA) Other: standard of care (nasal CPAP and supplemental oxygen) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA) |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Respiratory Distress Syndrome, Infant
Acute Respiratory Distress Syndrome
U.S. FDA Resources
Further study details as provided by University of Virginia:
Primary Outcome Measures:
- The primary outcome measure is reaching or not reaching failure criterion (FiO2= 65% while receiving nasal CPAP). [ Time Frame: 96 Hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of intubation [ Time Frame: Birth to discharge ] [ Designated as safety issue: No ]
- Nasal CPAP and requirement for supplemental oxygen [ Time Frame: Birth to discharge ] [ Designated as safety issue: No ]
- Time to reach full enteral feedings [ Time Frame: Birth to discharge ] [ Designated as safety issue: No ]
- Incidence of laryngeal edema [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
- Duration of hospitalization [ Time Frame: Birth to discharge ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 380 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Surfactant by LMA
|
Device: Surfactant administered via Laryngeal Mask Airway (LMA)
Standard volume of Infasurf surfactant (3 mL/kg) will be injected in 2-4 aliquots into the proximal end of the LMA.
Other Names:
|
|
2
Standard of care
|
Other: standard of care (nasal CPAP and supplemental oxygen)
Standard of care will be utilized which may mean surfactant is administered
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 72 Hours (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Birthweight > 1200 grams
- Chronologic age < 72 hours.
- Diagnosis of RDS by clinical and radiographic criteria.
- Treated with nasal CPAP and supplemental oxygen > 30% and not requiring > 60% FiO2 for longer than 30 minutes to maintain SaO2 88-95%.
- Parental consent.
Exclusion Criteria:
- Birthweight < 1200 gms.
- Diagnosis other than RDS (e.g., meconium aspiration syndrome).
- Babies who require or have already had endotracheal intubation.
- Babies with congenital anomalies or conditions thought by the attending physician to contribute to respiratory symptoms and/or to restrict adequate spontaneous breathing (e.g., congenital heart disease, obtundation from maternal drugs, certain airway malformations, diaphragmatic hernia).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00599651
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599651
Locations
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
Sponsors and Collaborators
University of Virginia
LMA North America
ONY
Investigators
| Principal Investigator: | John Kattwinkel, MD | University of Virginia |
More Information
| Responsible Party: | John Kattwinkel, MD, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00599651 History of Changes |
| Other Study ID Numbers: | 11851 |
| Study First Received: | December 29, 2007 |
| Last Updated: | May 6, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Virginia:
|
Respiratory Distress Syndrome Newborn RDS |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases Respiration Disorders |
Infant, Premature, Diseases Infant, Newborn, Diseases Pulmonary Surfactants Calfactant Respiratory System Agents |
ClinicalTrials.gov processed this record on September 23, 2016