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

NCT ID: NCT04056741

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-07
• Study Completion Date: 2026-03-12

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.

Conditions

RDS of Prematurity; Surfactant Protein B Deficiency; Chronic Lung Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surfactant administered via supraglottic administration device

Patients in this group will have Calfactant at 3ml/kg administered via the supraglottic administration device.

Group Type: EXPERIMENTAL

surfactant airway device

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 24 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ONY

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari Roberts, MD

Role: STUDY_CHAIR

Kari Roberts, MD - University of Minnesota, Minneapolis, MN

Locations

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Sisters of Charity Hospital

Buffalo, New York, United States

Jackson-Madison County General Hospital

Jackson, Tennessee, United States

Countries

United States

Other Identifiers

ProVia-01

Identifier Type: -

Identifier Source: org_study_id