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

• Sponsor: ONY (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04056741
• Collaborator: (none)
• Enrollment: 55
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 22.8
• Patients Per Site: 13.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
RDS of Prematurity; Surfactant Protein B Deficiency; Chronic Lung Disease	Combination Product: surfactant airway device	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pilot StudyPilot Study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study
• Actual Study Start Date: Feb 7, 2020
• Anticipated Primary Completion Date: Oct 31, 2020
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

1. Instillation failures [First 10 minutes after surfactant instillation.]

   Instillation failure is defined as a lack of clinical response

2. Treatment failure [First 3 days of life]

   "Treatment failure" defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation.

Secondary Outcome Measures

1. Clinical response [3 days]

   Duration of oxygen therapy

2. Clinical response [3 days]

   duration of non-invasive respiratory therapy

3. Clinical response [3 days]

   number of rescue surfactant doses

4. Clinical response [3 days]

   incidence of pulmonary air leak

5. Clinical response [3 days]

   pulmonary hemorrhage

6. Clinical response [defined as need for oxygen at 36 weeks post menstrual age]

   chronic lung disease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Weeks and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sharp Mary Birch Hospital for Women & Newborns	San Diego	California	United States	92123
2	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida	United States	33701
3	Sisters of Charity Hospital	Buffalo	New York	United States	14214
4	Jackson-Madison County General Hospital	Jackson	Tennessee	United States	38301

Sponsors and Collaborators

• ONY

Investigators

• Study Chair: Kari Roberts, MD, Kari Roberts, MD - University of Minnesota, Minneapolis, MN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ONY
• ClinicalTrials.gov Identifier: NCT04056741
• Other Study ID Numbers: ProVia-01
• First Posted: Aug 14, 2019
• Last Update Posted: Oct 23, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by ONY: Neonatal RDS; RDS; Surfactant Deficiency
• Additional relevant MeSH terms: Lung Diseases; Pulmonary Surfactants

Study Results

No Results Posted as of Oct 23, 2020