Respiratory Distress SyndromePhase 3NCT03058666
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
A Phase 3 study testing Aerosolized Calfactant and Solarys in people with Respiratory Distress Syndrome, run by ONY at 22 sites in United States.
Trial summary
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Aerosolized Calfactant and Solarys
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 477 participants
- Where
- 22 sitesUnited States
- Study dates
- 29 Mar 2017to 31 Jul 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- RDS Patients
- NICU patient, ≥1hour of age and <24 hours of age.
- Clinical diagnosis of RDS, with or without chest X-ray data.
- Inspired oxygen ≥21% to maintain adequate oxygen saturation.
- Not intubated
- Requiring:
- nasal continuous positive airway pressure (nCPAP).
Who cannot join
- Congenital anomaly limiting care options or requiring early surgery.
- Cardiopulmonary decompensation.
- hypotension with metabolic acidosis (base excess < -10 meq/l).
- Oxygen saturations < 88% at start of aerosolization.
- PaCO2 ≥ 60 mmHg at start of aerosolization.
- Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
- Acute hypoxic encephalopathy with or without seizures.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Sisters of Charity Hospital
Buffalo, New York, 14214
The Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virgina Medical Center
Charlottesville, Virginia, 22903
Columbus Regional Hospital
Columbus, Georgia, 31904
Pitt County Memorial Hospital
Greenville, North Carolina, 27835
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
Kentucky Children's Hospital, University of Kentucky Medical Center
Lexington, Kentucky, 40506
Baptist Hospital of Miami
Miami, Florida, 33176
Children's Hospital and Clinics
Minneapolis, Minnesota, 55404
USA Children's & Women's Hospital
Mobile, Alabama, 36604
Vanderbilt university Medical Center
Nashville, Tennessee, 37232
Timpanogos Regional Medical Center
Orem, Utah, 84057
Adventist Healthcare System, Florida Hospital
Orlando, Florida, 32803
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
Utah Valley Hospital
Provo, Utah, 84604
Children's Hospital Minnesota
Saint Paul, Minnesota, 55102
North central Baptist Hospital
San Antonio, Texas, 78258
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
University of South Florida, Tampa general
Tampa, Florida, 33606
About this study
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Read the detailed description
Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Aerosolized Calfactant, Solarys
- Keywords
- Aerosol, surfactant, calfactant, Infasurf, Respiratory Distress Syndrome, RDS, Premature, Neonates
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosolized CalfactantDrug
Also called Infasurf, Calfactant
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
SolarysDevice
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
| Study group | Role | What they receive |
|---|---|---|
| Aerosolized Calfactant | Experimental | 1. NICU Patients with a clinical diagnosis of RDS
2. Inspired oxygen ≥21% to maintain adequate oxygen saturation
3. Not Intubated
4. Requiring Nasal continuous positive airway pressure Receives: Drug: Aerosolized Calfactant; Device: Solarys |
| Usual Care | No intervention | There will be no protocol driven interventions in the usual care group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation and Instillation of Liquid Surfactant
Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.
Measured: 72 hours
Secondary outcomes (2)
Respiratory Support Requirements
Difference of Respiratory support at 28 days
Measured: 28 days
Air Leak
Percent of at risk subjects with air leak at any time
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start29 Mar 2017
- Primary completion1 Jun 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- ONY
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Cummings, MD, Study chair, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058666
- Sponsor's protocol ID
- Aero-02
- Status last verified
- May 2024
- First submitted
- 16 Feb 2017
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cummings JJ, Gerday E, Minton S, Katheria A, Albert G, Flores-Torres J, Famuyide M, Lampland A, Guthrie S, Kuehn D, Weitkamp JH, Fort P, Abu Jawdeh EG, Ryan RM, Martin GC, Swanson JR, Mulrooney N, Eyal F, Gerstmann D, Kumar P, Wilding GE, Egan EA; AERO-02 STUDY INVESTIGATORS. Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial. Pediatrics. 2020 Nov;146(5):e20193967. doi: 10.1542/peds.2019-3967. Epub 2020 Oct 15.
PubMed 33060258
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
- ClinicalTrials.gov ID
- NCT03058666
- Acronym / sponsor ID
- Aero-02
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Aerosol, surfactant, calfactant, Infasurf, Respiratory Distress Syndrome, RDS, Premature, Neonates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- ONYIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 29 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Detailed description
Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerosolized Calfactant | Experimental | Drug: Aerosolized Calfactant, Device: Solarys1. NICU Patients with a clinical diagnosis of RDS 2. Inspired oxygen ≥21% to maintain adequate oxygen saturation 3. Not Intubated 4. Requiring Nasal continuous positive airway pressure |
| Usual Care | No intervention | –There will be no protocol driven interventions in the usual care group. |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- RDS Patients
- NICU patient, ≥1hour of age and <24 hours of age.
- Clinical diagnosis of RDS, with or without chest X-ray data.
- Inspired oxygen ≥21% to maintain adequate oxygen saturation.
- Not intubated
Key exclusion criteria (7 listed)
- Congenital anomaly limiting care options or requiring early surgery.
- Cardiopulmonary decompensation.
- Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
- Acute hypoxic encephalopathy with or without seizures.
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 |
|---|---|---|
| Aerosolized CalfactantAlso: Infasurf, CalfactantAerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. | Drug | Aerosolized Calfactant |
| SolarysAerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. | Device | Aerosolized Calfactant |
Primary outcome
Intubation and Instillation of Liquid Surfactant
Time frame: 72 hours
Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.
2 secondary outcomes
Respiratory Support Requirements
Time frame: 28 days
Air Leak
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33060258Cummings JJ, Gerday E, Minton S, Katheria A, Albert G, Flores-Torres J, Famuyide M, Lampland A, Guthrie S, Kuehn D, Weitkamp JH, Fort P, Abu Jawdeh EG, Ryan RM, Martin GC, Swanson JR, Mulrooney N, Eyal F, Gerstmann D, Kumar P, Wilding GE, Egan EA; AERO-02 STUDY INVESTIGATORS. Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial. Pediatrics. 2020 Nov;146(5):e20193967. doi: 10.1542/peds.2019-3967. Epub 2020 Oct 15.
- Individual participant dataSharing planned: No
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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.
James Cummings, MD study chair
Albany Medical College
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aerosolized Calfactant and Solarys in people with Respiratory Distress Syndrome, run by ONY at 22 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intubation and Instillation of Liquid Surfactant (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058666, which also lists 1 linked publication.
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 29 May 2024.