Clinical trial NCT01116921: Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
Official title: Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: laryngeal mask airway
surfactant
respiratory distress syndrome
neonate
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 103
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.

Detailed description: Secondary outcomes were total number of hours on mechanical ventilation, CPAP and supplemental oxygen during the first 7 days of life and for the entire hospitalization. Other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks PMA), oxygen requirement at discharge, severe intraventricular hemorrhage (Grade 3/4), and periventricular leukomalacia.

Eligibility criteria: Inclusion Criteria:

* Gestational age at time of enrollment 28 0/7 to 35 6/7 weeks postmenstrual age
* Age less than or equal to 36 hours old
* On nCPAP 6 with supplemental oxygen requirement (Fi02 greater than or equal to 30%) for greater than or equal to 30 minutes (to maintain Sa02 between 88-92%)
* Chest radiograph and clinical presentation consistent with respiratory distress syndrome (tachypnea, retractions, nasal flaring, and/or grunting

Exclusion Criteria:

* Prior mechanical ventilation or surfactant administration
* Major congenital anomaly
* Abnormality of the airway
* Respiratory distress secondary to an etiology other than respiratory distress syndrome (pneumothorax, meconium aspiration syndrome, pneumonia, hypoxic-ischemic encephalopathy)
* Apgar score \< 5 at 5 minutes of age

Primary outcomes:
measure: Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.
timeFrame: Seven days
Secondary outcomes:
measure: Duration of CPAP Therapy
timeFrame: During first seven days of life
measure: Duration of Oxygen Therapy
timeFrame: During first seven days of life
measure: Incidence of Pulmonary Airleaks
timeFrame: First 7 days of life
measure: Incidence of Severe IVH or PVL
timeFrame: During hospitalization
measure: Incidence of Chronic Lung Disease
timeFrame: Measured at hospital discharge
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: San Diego
country: United States
facility: University of California- San Diego Medical Center
state: California
city: Maple Grove
country: United States
facility: Maple Grove Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Children's Hospital
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Hospital
state: Minnesota
city: St Paul
country: United States
facility: St Paul Children's Hospital
state: Minnesota
city: Madison
country: United States
facility: University of Wisconsin- Madison
state: Wisconsin
Study officials:
affiliation: University of Minnesota Masonic Children's Hospital
name: Kari D Roberts, M.D.
role: STUDY_CHAIR
affiliation: University of California, San Diego
name: Sijani Tipnis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St Paul Children's Hospital
name: Andrea L Lampland, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University
name: Allen Merritt, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maple Grove Hospital and North Memorial Hospital
name: Erin Stepka, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Julie Kessel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts KD, Brown R, Lampland AL, Leone TA, Rudser KD, Finer NN, Rich WD, Merritt TA, Czynski AJ, Kessel JM, Tipnis SM, Stepka EC, Mammel MC. Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial. J Pediatr. 2018 Feb;193:40-46.e1. doi: 10.1016/j.jpeds.2017.09.068. Epub 2017 Nov 22.