Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)
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ClinicalTrials.gov Identifier: NCT00599651 |
Recruitment Status
:
Terminated
(Study was closed due to extremely low enrollment)
First Posted
: January 24, 2008
Last Update Posted
: May 7, 2010
|
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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 |

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 |

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:
|
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
|
- The primary outcome measure is reaching or not reaching failure criterion (FiO2= 65% while receiving nasal CPAP). [ Time Frame: 96 Hours ]
- Duration of intubation [ Time Frame: Birth to discharge ]
- Nasal CPAP and requirement for supplemental oxygen [ Time Frame: Birth to discharge ]
- Time to reach full enteral feedings [ Time Frame: Birth to discharge ]
- Incidence of laryngeal edema [ Time Frame: 96 hours ]
- Duration of hospitalization [ Time Frame: Birth to discharge ]

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Ages Eligible for Study: | up to 72 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599651
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | John Kattwinkel, MD | University of Virginia |
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 Key Record Dates |
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 |