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

Chronic Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04056741
• Other study ID #: ProVia-01
• Status: Suspended
• Phase: Phase 2
• Start date: February 7, 2025
• Est. completion date: March 12, 2026

Study information

• Verified date: October 2023
• Source: ONY
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 55
• Est. completion date: March 12, 2026
• Est. primary completion date: December 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lung Disease
• Lung Diseases
• RDS of Prematurity
• Surfactant Protein B Deficiency

Intervention

Combination Product:
• surfactant 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.

Locations

Country	Name	City	State
United States	Sisters of Charity Hospital	Buffalo	New York
United States	Jackson-Madison County General Hospital	Jackson	Tennessee
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	Sharp Mary Birch Hospital for Women & Newborns	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
ONY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Instillation failures	Instillation failure is defined as a lack of clinical response	First 10 minutes after surfactant instillation.
Primary	Treatment failure	"Treatment failure" defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation.	First 3 days of life
Secondary	Clinical response	Duration of oxygen therapy	3 days
Secondary	Clinical response	duration of non-invasive respiratory therapy	3 days
Secondary	Clinical response	number of rescue surfactant doses	3 days
Secondary	Clinical response	incidence of pulmonary air leak	3 days
Secondary	Clinical response	pulmonary hemorrhage	3 days
Secondary	Clinical response	chronic lung disease	defined as need for oxygen at 36 weeks post menstrual age