Clinical trial NCT04056741: Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study
Official title: A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: RDS of Prematurity
Surfactant Protein B Deficiency
Chronic Lung Disease
Keywords: Neonatal RDS
RDS
Surfactant Deficiency
Lead sponsor: ONY
Sponsor class: INDUSTRY
First posted: 2019-08-14
Enrollment: 55
Sex: ALL
Minimum age (years): 24
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot Study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Instillation failures
timeFrame: First 10 minutes after surfactant instillation.
measure: Treatment failure
timeFrame: First 3 days of life
Secondary outcomes:
measure: Clinical response
timeFrame: 3 days
measure: Clinical response
timeFrame: 3 days
measure: Clinical response
timeFrame: 3 days
measure: Clinical response
timeFrame: 3 days
measure: Clinical response
timeFrame: 3 days
measure: Clinical response
timeFrame: defined as need for oxygen at 36 weeks post menstrual age
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women & Newborns
state: California
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Buffalo
country: United States
facility: Sisters of Charity Hospital
state: New York
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
Study officials:
affiliation: Kari Roberts, MD - University of Minnesota, Minneapolis, MN
name: Kari Roberts, MD
role: STUDY_CHAIR
References: