Chronic Lung Disease, RDS of Prematurity, Surfactant Protein B Deficiency
Conditions
Keywords
Neonatal RDS, RDS, Surfactant Deficiency
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTsurfactant airway device
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.
Sponsors
ONY
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot Study
Eligibility
Sex/Gender
ALL
Age
24 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
* Gestational age at the time of enrollment ≥ 24 0/7 weeks * Weight at the time of enrollment 500- 5000 grams * Age ≤ 24 hours old * Require non-invasive respiratory support (i.e. continuous positive airway pressure, high flow nasal cannula or non-invasive ventilation) * Require FiO2 ≤ 40% * Clinical diagnosis of RDS
Exclusion criteria
* Prior surfactant administration * Prior mechanical ventilation * Major congenital anomaly * Abnormality of the airway * Respiratory distress secondary to an etiology other than RDS (suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy) * Apgar score \< 5 at 5 minutes of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Instillation failures | First 10 minutes after surfactant instillation. | Instillation failure is defined as a lack of clinical response |
| Treatment failure | First 3 days of life | Treatment failure defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | 3 days | Duration of oxygen therapy |
Countries
United States
Outcome results
None listed