Neonatal Respiratory DistressNCT03582930
Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
A study testing Infasurf Aero in people with Neonatal Respiratory Distress, run by ONY at 5 sites in United States.
Trial summary
Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS). Currently, such therapy requires instillation of a liquid suspension into the trachea through an endotracheal tube. Read more about this study
- Who is it for?
- Ages Up to 42 weeks
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- Infasurf Aero
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Up to 42 weeks
- All sexes
- Child
Who may be able to join
- Two cohorts with different entry criteria are included. In cohort 1 are patients with a diagnosis of early RDS who are not intubated and have not received a liquid surfactant instillation. In cohort 2 are patients who received liquid surfactant in the first hour of life, have been extubated and whose RDS is worsening.
- Cohort 1 Inclusion Criteria
- NICU patient, <12 hours of age.
- Clinical diagnosis of RDS, with or without chest X-ray data.
- Inspired oxygen ≤40% to maintain adequate oxygen saturation.
- Not intubated
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- Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation.
- Cohort 2 Inclusion Criteria
- NICU patient, <24 hours of age who received liquid surfactant at ≤ 1 hour of age and was extubated.
- Clinical diagnosis of RDS, with or without chest X-ray data.
- Inspired oxygen ≤40% to maintain adequate oxygen saturation.
- Not intubated
- Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation.
Who cannot join
- 1) Requires >40% inspired oxygen to maintain acceptable oxygenation 2) Requires endotracheal intubation. 3) A co-existing medical condition that makes aerosol administration contraindicated in the judgment of the attending physician.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Sisters of Charity Hospital
Buffalo, New York, 14214
Pitt County Memorial Hospital
Greenville, North Carolina, 27835
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
Utah Valley Hospital
Provo, Utah, 84604
About this study
Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS). Currently, such therapy requires instillation of a liquid suspension into the trachea through an endotracheal tube. Endotracheal intubations have undesirable adverse effects on fragile premature infants. Instilling surfactant as a liquid suspension into the lung is associated with adverse events due to interruption of breathing in patients who already have respiratory insufficiency. This treatment protocol is expanded access that offers the opportunity for patients to receive aerosolized Infasurf prior to FDA acting on ONY Biotech's application for approval for commercial marketing of aerosolized Infasurf.
Read the detailed description
This Treatment Protocol will offer patients access to aerosolized Infasurf therapy at the time RDS is diagnosed if a patient is <12 hours of age and has not previously received liquid surfactant, or is <24 hours of age, and received liquid surfactant in the first hour after birth, was extubated and RDS is worsening. Parents must give informed consent. Up to 2 repeat doses of aerosolized Infasurf can be administered. Aerosolized Infasurf must be administered as described in the protocol. Adverse events at administration (if any) and all serious adverse events related or possibly related the aerosolized Infasurf therapy will be extracted from the medical record and reported to the sponsor, ONY Biotech. A copy of the discharge summary of patients will be collected by the sponsor using HIPAA compliant methodology for generation of a data set that will characterize adverse events and other efficacy and safety data.
- Conditions
- Neonatal Respiratory Distress
- Being tested
- Infasurf Aero
- Keywords
- Infasurf, Surfactant, RDS, Respiratory Distress Syndrome, Aerosolized, Nebulized, Inhaled, Pre-term, Premature
- Medical subject headings
- Pulmonary Atelectasis, Respiratory Distress Syndrome, Respiratory Aspiration, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infasurf AeroCombination product
Aerosolization of Infasurf administered to premature babies suffering from RDS. Successful administration of Infasurf by aerosolization will provide two important benefits for patients. (1) endotracheal intubation may be able to be avoided in some patients, and (2) the adverse events at instillation due to filling the airway with liquid and interrupting breathing may be diminished or abolished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- ONY
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Cummings, MD, Study chair, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582930
- Sponsor's protocol ID
- Aero-03
- Status last verified
- Oct 2022
- First submitted
- 27 Jun 2018
- Last updated
- 7 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
- ClinicalTrials.gov ID
- NCT03582930
- Acronym / sponsor ID
- Aero-03
- Conditions
- Neonatal Respiratory Distress
- Keywords
- Infasurf, Surfactant, RDS, Respiratory Distress Syndrome, Aerosolized, Nebulized, Inhaled, Pre-term
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- ONYIndustry (pharma, biotech, devices)
- First posted
- 11 Jul 2018 (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.
Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS). Currently, such therapy requires instillation of a liquid suspension into the trachea through an endotracheal tube. Endotracheal intubations have undesirable adverse effects on fragile premature infants. Instilling surfactant as a liquid suspension into the lung is associated with adverse events due to interruption of breathing in patients who already have respiratory insufficiency. This treatment protocol is expanded access that offers the opportunity for patients to receive aerosolized Infasurf prior to FDA acting on ONY Biotech's application for approval for commercial marketing of aerosolized Infasurf.
Detailed description
This Treatment Protocol will offer patients access to aerosolized Infasurf therapy at the time RDS is diagnosed if a patient is <12 hours of age and has not previously received liquid surfactant, or is <24 hours of age, and received liquid surfactant in the first hour after birth, was extubated and RDS is worsening. Parents must give informed consent. Up to 2 repeat doses of aerosolized Infasurf can be administered. Aerosolized Infasurf must be administered as described in the protocol. Adverse events at administration (if any) and all serious adverse events related or possibly related the aerosolized Infasurf therapy will be extracted from the medical record and reported to the sponsor, ONY Biotech. A copy of the discharge summary of patients will be collected by the sponsor using HIPAA compliant methodology for generation of a data set that will characterize adverse events and other efficacy and safety data.
Study design
Who may qualify
- Ages
- Up to 42 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (13 listed)
- Two cohorts with different entry criteria are included. In cohort 1 are patients with a diagnosis of early RDS who are not intubated and have not received a liquid surfactant instillation. In cohort 2 are patients who received liquid surfactant in the first hour of life, have been extubated and whose RDS is worsening.
- Cohort 1 Inclusion Criteria
- NICU patient, <12 hours of age.
- Clinical diagnosis of RDS, with or without chest X-ray data.
- Inspired oxygen ≤40% to maintain adequate oxygen saturation.
Key exclusion criteria (1 listed)
- 1) Requires >40% inspired oxygen to maintain acceptable oxygenation 2) Requires endotracheal intubation. 3) A co-existing medical condition that makes aerosol administration contraindicated in the judgment of the attending physician.
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 AeroAerosolization of Infasurf administered to premature babies suffering from RDS. Successful administration of Infasurf by aerosolization will provide two important benefits for patients. (1) endotracheal intubation may be able to be avoided in some patients, and (2) the adverse events at instillation due to filling the airway with liquid and interrupting breathing may be diminished or abolished. | Combination product | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
Jim Cummings, MD study chair
Albany Medical College
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infasurf Aero in people with Neonatal Respiratory Distress, run by ONY at 5 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 13 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 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 5 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.
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.
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 7 Nov 2023.