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

NCT04056741 | Suspended Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: ProVia-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Neonatal RDS; RDS; Surfactant Deficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Clinical response

  3 days

• Clinical response

  3 days

• Clinical response

  3 days

• Clinical response

  3 days

• Clinical response

  3 days

Study Arms (1)

Surfactant administered via supraglottic administration device

EXPERIMENTAL

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

Combination Product: surfactant airway device

Interventions

surfactant airway device 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.

Surfactant administered via supraglottic administration device

Eligibility Criteria

• Age: 24 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ONY: lead

Study Sites (4)

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Sisters of Charity Hospital

Buffalo, New York, 14214, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Surfactant Metabolism Dysfunction, Pulmonary, 1

Study Officials

• Kari Roberts, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot Study

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 14, 2019
• Study Start: February 7, 2025
• Primary Completion: December 12, 2025
• Study Completion: March 12, 2026
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

US (4)