A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.
Surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant insufficiency, also known as respiratory distress syndrome (RDS). All commercially available surfactants for clinical use are approved for administration through an endotracheal tube. Placement of an endotracheal tube, a procedure called intubation, is stressful for the infant and associated with significant adverse effects. The proposed supraglottic instillation device allows infants to benefit from surfactant therapy while avoiding the negative effects of intubation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Infants who meet eligibility criteria and have a signed consent form by their parent or guardian will be enrolled in the study. Once enrolled, the surfactant airway device placement and surfactant administration will occur as detailed in the protocol. The infant will be monitored. If the infant meets instillation failure criteria, the procedure will be repeated shortly after the initial procedure. A maximum of two (2) doses will be given during the initial procedure. If the infant meets re-dosing criteria, (s)he may receive up to two (2) additional doses through the surfactant airway device (initial procedure with 1-2 doses and up to two additional doses). If at any time the infant reaches treatment failure criteria, the infant would be intubated and receive a site-specific surfactant through an endotracheal tube. Study outcome data will be followed until discharge from the NICU.
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Sisters of Charity Hospital
Buffalo, New York, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Instillation failures
Instillation failure is defined as a lack of clinical response
Time frame: First 10 minutes after surfactant instillation.
Treatment failure
"Treatment failure" defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation.
Time frame: First 3 days of life
Clinical response
Duration of oxygen therapy
Time frame: 3 days
Clinical response
duration of non-invasive respiratory therapy
Time frame: 3 days
Clinical response
number of rescue surfactant doses
Time frame: 3 days
Clinical response
incidence of pulmonary air leak
Time frame: 3 days
Clinical response
pulmonary hemorrhage
Time frame: 3 days
Clinical response
chronic lung disease
Time frame: defined as need for oxygen at 36 weeks post menstrual age
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