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Slow enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen 1 | Experimental |
| |
| Regimen 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosolized lucinactant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Respiratory Distress Syndrome | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiOâ‚‚) | AUC for FiOâ‚‚calculated using the trapezoidal rule. Missing data imputed using last observation carried forward | 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours |
| Arterial Alveolar (a/A) Oâ‚‚Ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Finer, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego Medical Center - Hillcrest | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20455772 | Result | 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. |
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Neonates were enrolled between January and August, 2005. This was an open-label study with 2 treatment groups (Regimen 1 and Regimen 2). Eligible neonates were sequentially enrolled and stratified by GA into 2 strata for each regimen. For each regimen, enrollment in Stratum 1 (30 to 32 GA) was completed before enrollment in Stratum 2 (28 to 29 GA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lucinactant - 3 Hour Interval | Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours |
| FG001 | Lucinactant - 1 Hour Interval | Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lucinactant - 3 Hour Interval | Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours |
| BG001 | Lucinactant - 1 Hour Interval |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Respiratory Distress Syndrome | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 24 hours |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lucinactant - 3 Hour Interval | Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis neonatal | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Segal, MD | Discovery Laboratories, Inc. | 215-488-9300 | rsegal@discoverylabs.com |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007752 | Obstetric Labor, Premature |
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|
| Aerosolized lucinactant | Drug | 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. |
|
|
a/A ratio is a relative way to judge the lungs ability to transport Oâ‚‚. It compares the partial pressure of Oâ‚‚in the alveoli (A) to the partial pressure of Oâ‚‚in the artery (a). It is calculated by dividing the partial pressure of Oâ‚‚in the artery, abbreviated PaO2, by the partial pressure of Oâ‚‚in 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. |
| 72 hours |
| Time to Meet Failure Criteria | Failure criteria defined as rescue with bolus surfactant and mechanical ventilation | Through 28 days |
| Number of Participants With Bronchopulmonary Dysplasia (BPD) | 28 days |
| Number of Participants Alive and Without BPD | 28 days |
| Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL) | 28 days |
| Number of Participants With Patent Ductus Arteriosus (PDA) | 28 days |
| Number of Participants With Necrotizing Enterocolitis (NEC) | 28 days |
| Number of Participants With Pulmonary Hemorrhage | 28 days |
| Number of Participants With Acquired Sepsis | 28 days |
| Incidence of Mortality | 28 days |
| Number of Participants With Air Leak | 28 days |
Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational Age | Mean | Standard Deviation | weeks |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiOâ‚‚) | AUC for FiOâ‚‚calculated using the trapezoidal rule. Missing data imputed using last observation carried forward | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Mean | Standard Deviation | percent Oâ‚‚*hours | 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours |
|
|
|
| Secondary | Arterial Alveolar (a/A) Oâ‚‚Ratio | a/A ratio is a relative way to judge the lungs ability to transport Oâ‚‚. It compares the partial pressure of Oâ‚‚in the alveoli (A) to the partial pressure of Oâ‚‚in the artery (a). It is calculated by dividing the partial pressure of Oâ‚‚in the artery, abbreviated PaO2, by the partial pressure of Oâ‚‚in 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. | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Mean | Standard Deviation | mm Hg over mm Hg (ratio of pressures) | 72 hours |
|
|
|
| Secondary | Time to Meet Failure Criteria | Failure criteria defined as rescue with bolus surfactant and mechanical ventilation | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). Time in days calculated for neonates who met failure criteria (3 for Regimen 1, 2 for Regimen 2) | Posted | Mean | Standard Deviation | days | Through 28 days |
|
|
|
| Secondary | Number of Participants With Bronchopulmonary Dysplasia (BPD) | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Number of Participants Alive and Without BPD | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL) | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Number of Participants With Patent Ductus Arteriosus (PDA) | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Number of Participants With Necrotizing Enterocolitis (NEC) | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Number of Participants With Pulmonary Hemorrhage | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Number of Participants With Acquired Sepsis | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Incidence of Mortality | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Number of Participants With Air Leak | This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| 5 |
| 11 |
| 11 |
| 11 |
| EG001 | Lucinactant - 1 Hour Interval | Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour | 1 | 6 | 6 | 6 |
| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
|
| Neonatal apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary hypertension NOS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Bradycardia NOS | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastro-oesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oedema NOS | General disorders | MedDRA | Systematic Assessment |
|
| Jaundice neonatal | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Abscess NOS | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia NOS | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis neonatal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
|
| Acidosis NOS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia NOS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia neonatal | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Metabolic acidosis NOS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Feeding problem in newborn | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| Agitation neonatal | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Nasal passage irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Neonatal apnoeic attach | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Intraventricular haemorrhage neonatal | Vascular disorders | MedDRA | Systematic Assessment |
|
| Neonatal hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pulmonary hypertension NOS | Vascular disorders | MedDRA | Systematic Assessment |
|
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |