Respiratory Distress Syndrome (Neonatal)Phase 3Aero-05NCT05960929
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
A Phase 3 study testing Infasurf Aero™ in people with Respiratory Distress Syndrome (Neonatal) and Intubation Complication, run by ONY at 10 sites in United States.
Trial summary
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support. Read more about this study
- Who is it for?
- Ages 29 to 36 weeks
- Conditions the study is for
- Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal
- What is being tested?
- Infasurf Aero™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Jan 2025to 1 Apr 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 29 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent obtained by parent or legal representative prior to or after birth
- Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
- Birthweight ≥ 1,000 AND ≤ 3,500 grams
- Age ≥ 1 hour AND ≤ 6 hours
- Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation
- Require CPAP
- Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
- If subject is >346/7 weeks' gestation a chest radiograph is required
Who cannot join
- Surfactant administration prior to randomization
- Mechanical ventilation prior to randomization
- Major congenital anomaly (suspected or confirmed)
- Abnormality of the airway (suspected or confirmed)
- Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
- Apgar score < 3 at 5 minutes of age
- Umbilical cord gas pH <7.0 or BD > 10
- Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Sisters of Charity Hospital
Buffalo, New York, 14214
George Albert, MD, 716-862-1000
George Albert, MD
- Recruiting
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, 96826
micah Tong, (808) 983-6000, micah.tong@hawaiipacifichealth.org
Sheri Kuo, MD
- Recruiting
Western TN- Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
Laura Choate, BSN, (731) 541-5000, laura.choate@wth.org
Scott Guthrie, MD
- Recruiting
University of Florida -Jacksonville
Jacksonville, Florida, 32209
Kimberly Barnett, (904) 244-0411, kimberly.barnette@jax.ufl.edu
Henry Zapata Galarza, MD
- Recruiting
Unity Point Meriter
Madison, Wisconsin, 53715
Shayla Schwingle Study Coordinator, (608) 417-6000, snschwingle@wisc.edu
Dinushuan Kaluarachchi, MD
- Recruiting
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Chris DeBari, 1-732-775-5500, christopher.debari@hmhn.org
Ann Ross, MD
- Recruiting
St. Josephs Hospital and Medical Center
Phoenix, Arizona, 85013
Serena Stewart, (602) 406-3000, serena.stewart@commonspirit.org
mohammed Elkhwad, MD
- Recruiting
Phoenix Children's
Phoenix, Arizona, 85016
Kathie Laitano, 602-933-1000, klaitano@phoenixchildrens.com
Greg Martin, MD
- Recruiting
Utah Valley Hospital
Provo, Utah, 84604
Jennifer Elmont, 801-507-7036, Jennifer.Elmont@imail.org
Steven Minton, MD
- Recruiting
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Alona Diem, 858-939-4301, Alona.Diem@sharp.com]
Anup Katheria, MD
About this study
Official title: InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.
Read the detailed description
This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.
The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered through the InfasurfAero.
Subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.
- Being tested
- Infasurf Aero™
- Keywords
- Infasurf, Calfactant, Inhalation, Nebulization, Preterm, InfasurfAero, Respiratory Distress Syndrome, Neonatal, NICU, CPAP, Intubation, Aerosol, CPAP Failure
- Medical subject headings
- Pulmonary Atelectasis, Perinatal Death, Respiratory Aspiration, Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infasurf Aero™Combination product
A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion. Receives: Combination Product: Infasurf Aero™ |
| Control Arm | Sham comparator | Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion. Receives: Combination Product: Infasurf Aero™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP failure and or death
CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) >2.5 on two consecutive assessments at least 30 minutes apart, or an RSS > 2.4 and one or more of the following:
(i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support.
(ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation).
(iii) Respiratory acidosis (pCO2 > 65 with a pH < 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.
Measured: Within 1st week of age
Secondary outcomes (7)
Chronic lung disease and or death
Chronic lung disease is defined as altitude adjusted oxygen requirement at 36 weeks post menstrual age.
Measured: 36 weeks post menstrual age (PMA).
Incidence of MV
Incidence of Mechanical Ventilation
Measured: 36 weeks PMA
Duration of MV
length of time of Mechanical Ventilation
Measured: 36 weeks PMA
Incidence of intubation
Any occurrence of tracheal intubation
Measured: 36 weeks PMA
Incidence of invasive surfactant replacement therapy
any occurrence of liquid surfactant administration via and endotracheal tube
Measured: 72 hours post birth
Duration of non-invasive support
Length of time of respiratory support other than Intubation
Measured: 36 weeks PMA
Duration of supplemental oxygen
Length of time any oxygen is administered.
Measured: 36 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome (Neonatal)Studies 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
- Model description
- This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ONY
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Scott Guthrie, MD, Study chair, Vanderbilt Jackson-Madison, Jackson TNDinushan Kaluarachchi, MD, Study chair, Unity Point Meriter, Madison WIJim Cummings, MD, Study director, Ony Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960929
- Sponsor's protocol ID
- AERO-05 Protocol
- Acronym
- Aero-05
- Status last verified
- Nov 2024
- First submitted
- 6 Jul 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial
- ClinicalTrials.gov ID
- NCT05960929
- Acronym / sponsor ID
- Aero-05 / AERO-05 Protocol
- Keywords
- Infasurf, Calfactant, Inhalation, Nebulization, Preterm, InfasurfAero, Respiratory Distress Syndrome, Neonatal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- ONYIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 27 Jul 2023 (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.
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.
Detailed description
This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.
The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered through the InfasurfAero.
Subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Combination Product: Infasurf Aero™A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion. |
| Control Arm | Sham comparator | Combination Product: Infasurf Aero™Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion. |
Who may qualify
- Ages
- 29 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Written informed consent obtained by parent or legal representative prior to or after birth
- Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
- Birthweight ≥ 1,000 AND ≤ 3,500 grams
- Age ≥ 1 hour AND ≤ 6 hours
- Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation
Key exclusion criteria (8 listed)
- Surfactant administration prior to randomization
- Mechanical ventilation prior to randomization
- Major congenital anomaly (suspected or confirmed)
- Abnormality of the airway (suspected or confirmed)
- Respiratory distress presumed secondary to an etiology other than RDS (e.g., 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 |
|---|---|---|
| Infasurf Aero™A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg. | Combination product | Control Arm, Treatment Arm |
Primary outcome
CPAP failure and or death
Time frame: Within 1st week of age
CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) >2.5 on two consecutive assessments at least 30 minutes apart, or an RSS > 2.4 and one or more of the following: (i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support. (ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation). (iii) Respiratory acidosis (pCO2 > 65 with a pH < 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.
7 secondary outcomes
Chronic lung disease and or death
Time frame: 36 weeks post menstrual age (PMA).
Incidence of MV
Time frame: 36 weeks PMA
Duration of MV
Time frame: 36 weeks PMA
Incidence of intubation
Time frame: 36 weeks PMA
Incidence of invasive surfactant replacement therapy
Time frame: 72 hours post birth
Duration of non-invasive support
Time frame: 36 weeks PMA
Duration of supplemental oxygen
Time frame: 36 weeks PMA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- 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.
Scott Guthrie, MD study chair
Vanderbilt Jackson-Madison, Jackson TN
Dinushan Kaluarachchi, MD study chair
Unity Point Meriter, Madison WI
Jim Cummings, MD study director
Ony Biotech
10 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 Infasurf Aero™ in people with Respiratory Distress Syndrome (Neonatal) and Intubation Complication, run by ONY at 10 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corey Commaroto, RRT (7163614659, ccommaroto@onybiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP failure and or death (time frame: Within 1st week of age). 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 30 Mar 2025.