Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Respiratory Distress Syndrome, Newborn	Device: Surfactant administered via Laryngeal Mask Airway (LMA); Other: standard of care (nasal CPAP and supplemental oxygen)	Not Applicable

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	380 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)
Study Start Date :	June 2005
Estimated Primary Completion Date :	June 2009
Estimated Study Completion Date :	December 2009

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The primary outcome measure is reaching or not reaching failure criterion (FiO2= 65% while receiving nasal CPAP). [ Time Frame: 96 Hours ]

Secondary Outcome Measures :

1. Duration of intubation [ Time Frame: Birth to discharge ]
2. Nasal CPAP and requirement for supplemental oxygen [ Time Frame: Birth to discharge ]
3. Time to reach full enteral feedings [ Time Frame: Birth to discharge ]
4. Incidence of laryngeal edema [ Time Frame: 96 hours ]
5. Duration of hospitalization [ Time Frame: Birth to discharge ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 72 Hours (Child)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	John Kattwinkel, MD, University of Virginia
ClinicalTrials.gov Identifier:	NCT00599651 History of Changes
Other Study ID Numbers:	11851
First Posted:	January 24, 2008
Last Update Posted:	May 7, 2010
Last Verified:	May 2010

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