Respiratory Distress SyndromePhase 2NCT00807235
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
A Phase 2 study testing Aerosolized lucinactant in people with Respiratory Distress Syndrome, run by Windtree Therapeutics at 1 site in United States.
Trial summary
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants. Read more about this study
- Who is it for?
- Ages 15 to 30 minutes
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Aerosolized lucinactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Sep 2005
- Phase
- Phase 2
- 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 15 to 30 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age 28-32 completed weeks, inclusive
- Placement of arterial line
- Successful initiation of nCPAP
- Informed Consent
Who cannot join
- Heart rate that cannot be stabilized >100 bpm within 5 minutes of birth
- Five (5) minute Apgar score ≤ 3
- Major congenital malformation(s) diagnosed antenatally or noted immediately after birth
- Other disease(s) or conditions potentially interfering with cardiopulmonary function
- Mother with prolonged rupture of membranes > 2 weeks
- Known or suspected chromosomal abnormality
- Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room
- Need for mechanical ventilation within 30 minutes of birth
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego Medical Center - Hillcrest
San Diego, California, 92103
About this study
Official title: An Open Label, Multicenter, Phase 2, Pilot Evaluation of SURFAXIN®(Lucinactant) Delivered as an Aerosol Via Nasal Continuous Positive Airway Pressure (nCPAP) in the Prevention of Respiratory Distress Syndrome in Premature Infants
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
Read the detailed description
Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Aerosolized lucinactant
- Keywords
- Lucinactant, Nasal continuous positive airway pressure (nCPAP), Respiratory distress syndrome (RDS), Pediatric, Premature
- 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 lucinactantDrug
Also called KL₄Surfactant
Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.
Aerosolized lucinactantDrug
Also called KL₄Surfactant
Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Experimental | Not described Receives: Drug: Aerosolized lucinactant |
| Regimen 2 | Experimental | Not described Receives: Drug: Aerosolized lucinactant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Respiratory Distress Syndrome
Measured: 24 hours
Secondary outcomes (12)
Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)
AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Measured: 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours
Arterial Alveolar (a/A) O₂Ratio
a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.
Measured: 72 hours
Time to Meet Failure Criteria
Failure criteria defined as rescue with bolus surfactant and mechanical ventilation
Measured: Through 28 days
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Measured: 28 days
Number of Participants Alive and Without BPD
Measured: 28 days
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)
Measured: 28 days
Number of Participants With Patent Ductus Arteriosus (PDA)
Measured: 28 days
Number of Participants With Necrotizing Enterocolitis (NEC)
Measured: 28 days
Number of Participants With Pulmonary Hemorrhage
Measured: 28 days
Number of Participants With Acquired Sepsis
Measured: 28 days
Incidence of Mortality
Measured: 28 days
Number of Participants With Air Leak
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 posted11 Dec 2008 (estimated)
- Study startJan 2005
- Primary completionAug 2005
- Study completionSep 2005
Why it stopped: Slow enrollment
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Windtree Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Finer, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807235
- Sponsor's protocol ID
- KL4-CPAP-01
- Status last verified
- May 2012
- First submitted
- 10 Dec 2008
- Last updated
- 13 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Segal R. An open label, pilot study of Aerosurf(R) combined with nCPAP to prevent RDS in preterm neonates. J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):303-9. doi: 10.1089/jamp.2009.0758.
PubMed 20455772
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Phase 2, Pilot Evaluation of SURFAXIN®(Lucinactant) Delivered as an Aerosol Via Nasal Continuous Positive Airway Pressure (nCPAP) in the Prevention of Respiratory Distress Syndrome in Premature Infants
- ClinicalTrials.gov ID
- NCT00807235
- Acronym / sponsor ID
- KL4-CPAP-01
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Lucinactant, Nasal continuous positive airway pressure (nCPAP), Respiratory distress syndrome (RDS), Pediatric, Premature
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Windtree TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Posted 13 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
Detailed description
Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 | Experimental | Drug: Aerosolized lucinactant |
| Regimen 2 | Experimental | Drug: Aerosolized lucinactant |
Who may qualify
- Ages
- 15 to 30 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age 28-32 completed weeks, inclusive
- Placement of arterial line
- Successful initiation of nCPAP
- Informed Consent
Key exclusion criteria (8 listed)
- Heart rate that cannot be stabilized >100 bpm within 5 minutes of birth
- Five (5) minute Apgar score ≤ 3
- Major congenital malformation(s) diagnosed antenatally or noted immediately after birth
- Other disease(s) or conditions potentially interfering with cardiopulmonary function
- Mother with prolonged rupture of membranes > 2 weeks
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 lucinactantAlso: KL₄SurfactantAerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours. | Drug | Regimen 1 |
| Aerosolized lucinactantAlso: KL₄SurfactantAerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour. | Drug | Regimen 2 |
Primary outcome
Number of Participants With Respiratory Distress Syndrome
Time frame: 24 hours
12 secondary outcomes
Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)
Time frame: 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours
Arterial Alveolar (a/A) O₂Ratio
Time frame: 72 hours
Time to Meet Failure Criteria
Time frame: Through 28 days
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Time frame: 28 days
Number of Participants Alive and Without BPD
Time frame: 28 days
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)
Time frame: 28 days
Number of Participants With Patent Ductus Arteriosus (PDA)
Time frame: 28 days
Number of Participants With Necrotizing Enterocolitis (NEC)
Time frame: 28 days
Number of Participants With Pulmonary Hemorrhage
Time frame: 28 days
Number of Participants With Acquired Sepsis
Time frame: 28 days
Incidence of Mortality
Time frame: 28 days
Number of Participants With 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 13 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20455772Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Segal R. An open label, pilot study of Aerosurf(R) combined with nCPAP to prevent RDS in preterm neonates. J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):303-9. doi: 10.1089/jamp.2009.0758.
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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.
Neil Finer, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerosolized lucinactant in people with Respiratory Distress Syndrome, run by Windtree Therapeutics at 1 site 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 4 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: stopped early, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Jun 2012). 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?
Number of Participants With Respiratory Distress Syndrome (time frame: 24 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 NCT00807235, 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 13 Jun 2012.