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

NCT00599651 | Terminated

• 1 other identifier: 11851
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Respiratory Distress Syndrome; Newborn RDS

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is reaching or not reaching failure criterion (FiO2= 65% while receiving nasal CPAP).

  96 Hours

Secondary Outcomes (5)

• Duration of intubation

  Birth to discharge

• Nasal CPAP and requirement for supplemental oxygen

  Birth to discharge

• Time to reach full enteral feedings

  Birth to discharge

• Incidence of laryngeal edema

  96 hours

• Duration of hospitalization

  Birth to discharge

Study Arms (2)

1

EXPERIMENTAL

Surfactant by LMA

Device: Surfactant administered via Laryngeal Mask Airway (LMA)

2

OTHER

Standard of care

Other: standard of care (nasal CPAP and supplemental oxygen)

Interventions

Surfactant administered via Laryngeal Mask Airway (LMA) DEVICE

Standard volume of Infasurf surfactant (3 mL/kg) will be injected in 2-4 aliquots into the proximal end of the LMA.

Also known as: Infasurf, LMA

1

standard of care (nasal CPAP and supplemental oxygen) OTHER

Standard of care will be utilized which may mean surfactant is administered

2

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Virginia: lead
• LMA North America: collaborator
• ONY: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Abdel-Latif ME, Walker E, Osborn DA. Laryngeal mask airway surfactant administration for prevention of morbidity and mortality in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2024 Jan 25;1(1):CD008309. doi: 10.1002/14651858.CD008309.pub3.

  PMID: 38270182 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Pulmonary Atelectasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• John Kattwinkel, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2007
• First Posted: January 24, 2008
• Study Start: June 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 7, 2010

Record last verified: 2010-05

Locations

US (1)