A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- RDS of Prematurity
- Sponsor
- ONY
- Enrollment
- 55
- Locations
- 4
- Primary Endpoint
- Treatment failure
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Treatment failure
Time Frame: First 3 days of life
"Treatment failure" defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation.
Instillation failures
Time Frame: First 10 minutes after surfactant instillation.
Instillation failure is defined as a lack of clinical response
Secondary Outcomes
- Clinical response(defined as need for oxygen at 36 weeks post menstrual age)