RDS of PrematurityPhase 2NCT04056741
Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study
A Phase 2 study testing surfactant airway device in people with RDS of Prematurity and Surfactant Protein B Deficiency, run by ONY at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 weeks and older
- Conditions the study is for
- RDS of Prematurity, Surfactant Protein B Deficiency, Chronic Lung Disease
- What is being tested?
- surfactant airway device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Feb 2025to 12 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Sisters of Charity Hospital
Buffalo, New York, 14214
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study
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.
Read the 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.
- Being tested
- surfactant airway device
- Keywords
- Neonatal RDS, RDS, Surfactant Deficiency
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants, Surfactant Metabolism Dysfunction, Pulmonary, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surfactant airway deviceCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Surfactant administered via supraglottic administration device | Experimental | Patients in this group will have Calfactant at 3ml/kg administered via the supraglottic administration device. Receives: Combination Product: surfactant airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instillation failures
Instillation failure is defined as a lack of clinical response
Measured: First 10 minutes after surfactant instillation.
Treatment failure
"Treatment failure" defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation.
Measured: First 3 days of life
Secondary outcomes (6)
Clinical response
Duration of oxygen therapy
Measured: 3 days
Clinical response
duration of non-invasive respiratory therapy
Measured: 3 days
Clinical response
number of rescue surfactant doses
Measured: 3 days
Clinical response
incidence of pulmonary air leak
Measured: 3 days
Clinical response
pulmonary hemorrhage
Measured: 3 days
Clinical response
chronic lung disease
Measured: defined as need for oxygen at 36 weeks post menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start7 Feb 2025 (estimated)
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Mar 2026 (estimated)
Why it stopped: alteration of study required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RDS of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot Study
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ONY
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kari Roberts, MD, Study chair, Kari Roberts, MD - University of Minnesota, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056741
- Sponsor's protocol ID
- ProVia-01
- Status last verified
- Oct 2023
- First submitted
- 6 Aug 2019
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study
- ClinicalTrials.gov ID
- NCT04056741
- Acronym / sponsor ID
- ProVia-01
- Keywords
- Neonatal RDS, RDS, Surfactant Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: alteration of study required
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- ONYIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (estimated)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Mar 2026 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Surfactant administered via supraglottic administration device | Experimental | Combination Product: surfactant airway devicePatients in this group will have Calfactant at 3ml/kg administered via the supraglottic administration device. |
Who may qualify
- Ages
- 24 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surfactant airway deviceInfants 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. | Combination product | Surfactant administered via supraglottic administration device |
Primary outcome
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.
6 secondary outcomes
Clinical response
Time frame: 3 days
Clinical response
Time frame: 3 days
Clinical response
Time frame: 3 days
Clinical response
Time frame: 3 days
Clinical response
Time frame: 3 days
Clinical response
Time frame: defined as need for oxygen at 36 weeks post menstrual age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Roberts, MD study chair
Kari Roberts, MD - University of Minnesota, Minneapolis, MN
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing surfactant airway device in people with RDS of Prematurity and Surfactant Protein B Deficiency, run by ONY at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instillation failures (time frame: First 10 minutes after surfactant instillation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.