Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study

Study 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.

Official Title
-----------------
A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study

Conditions
-----------------
RDS of Prematurity, Surfactant Protein B Deficiency, Chronic Lung Disease

Intervention / Treatment
-----------------
* Combination Product: surfactant airway device


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surfactant administered via supraglottic administration device<br>Patients in this group will have Calfactant at 3ml/kg administered via the supraglottic administration device. | Combination Product: surfactant airway device<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instillation failures | Instillation failure is defined as a lack of clinical response | First 10 minutes after surfactant instillation. | 
| Treatment failure | Treatment failure defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation. | First 3 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Duration of oxygen therapy | 3 days | 
| Clinical response | duration of non-invasive respiratory therapy | 3 days | 
| Clinical response | number of rescue surfactant doses | 3 days | 
| Clinical response | incidence of pulmonary air leak | 3 days | 
| Clinical response | pulmonary hemorrhage | 3 days | 
| Clinical response | chronic lung disease | defined as need for oxygen at 36 weeks post menstrual age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal RDS, RDS, Surfactant Deficiency