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

Phase 2

Suspended

• Conditions: RDS of Prematurity; Chronic Lung Disease; Surfactant Protein B Deficiency
• Interventions: Combination Product: surfactant airway device

• Registration Number: NCT04056741
• Lead Sponsor: ONY

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.

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01
• Study Start: 2025-02-07
• Primary Completion: 2025-12-12
• Study Completion: 2026-03-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surfactant administered via supraglottic administration device	surfactant airway device	Patients in this group will have Calfactant at 3ml/kg administered via the supraglottic administration device.

Primary Outcome Measures

Name	Time	Method
Treatment failure	First 3 days of life	"Treatment failure" defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation.
Instillation failures	First 10 minutes after surfactant instillation.	Instillation failure is defined as a lack of clinical response

Secondary Outcome Measures

Name	Time	Method
Clinical response	defined as need for oxygen at 36 weeks post menstrual age	chronic lung disease

Trial Locations

Locations (4)

Johns Hopkins All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States

Sharp Mary Birch Hospital for Women & Newborns; 🇺🇸 San Diego, California, United States

Sisters of Charity Hospital; 🇺🇸 Buffalo, New York, United States

Jackson-Madison County General Hospital; 🇺🇸 Jackson, Tennessee, United States