Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA) - Full Text View

Sponsor:	University of Virginia
Collaborators:	LMA North America ONY
Information provided by:	University of Virginia
ClinicalTrials.gov Identifier:	NCT00599651

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:

MedlinePlus related topics: Oxygen Therapy

Drug Information available for: Calfactant

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: Infasurf LMA
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
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

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

No publications provided

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012