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

Overview

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.

Full Title of Study: “A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 12, 2025

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.

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 24 Weeks

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ONY
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kari Roberts, MD, Study Chair, Kari Roberts, MD – University of Minnesota, Minneapolis, MN

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