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| ID | Type | Description | Link |
|---|---|---|---|
| FD-R-001938 | Other Grant/Funding Number | US Department of Health and Human Services |
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Slow enrollment and administrative reasons
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OBJECTIVES:
Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
PROTOCOL OUTLINE:
This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses.
Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization.
Patients are followed for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucinactant | Experimental | Lucinactant via bronchoaveolar lavage |
|
| Standard Care | Other | Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucinactant | Drug | Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Receiving Mechanical Ventilation (MV) | A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Death | 28 days | |
| Number of Participants With Air Leaks | Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E Wiswell | Windtree Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Discovery Laboratories, Inc. | Warrington | Pennsylvania | 18976 | United States |
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Recruitment occurred between March 2000 and October 2002. Infants were enrolled from neonatal intensive care units and were randomized to open-label study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lucinactant | Lucinactant via bronchoaveolar lavage |
| FG001 | Standard Care | Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lucinactant | Lucinactant via bronchoaveolar lavage |
| BG001 | Standard Care | Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization |
| 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 Days Receiving Mechanical Ventilation (MV) | A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV. | Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%. All enrolled infants were analyzed (intent-to-treat). | Posted | Mean | Standard Deviation | days | 28 days |
|
28 Days
AEs followed until resolution or stable condition
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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 | Lucinactant via bronchoaveolar lavage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia NOS | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia NOS | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Early termination led to a small number of subjects analyzed. Results should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Segal | Discovery Laboratories, Inc. | 215-488-9300 | rsegal@discoverylabs.com |
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| ID | Term |
|---|---|
| D008471 | Meconium Aspiration Syndrome |
| D012140 | Respiratory Tract Diseases |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
| D005315 | Fetal Diseases |
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| ID | Term |
|---|---|
| C502722 | lucinactant |
| D013501 | Surface-Active Agents |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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|
|
| Standard Care | Other | The Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC |
|
|
| 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 |
|
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization |
|
|
| Secondary | Incidence of Death | Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%. All enrolled infants were analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Number of Participants With Air Leaks | Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium | Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%. All enrolled infants were analyzed (intent-to-treat). | Posted | Number | participants | 28 days |
|
|
|
| 23 |
| 38 |
| 36 |
| 38 |
| EG001 | Standard Care | Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization | 14 | 31 | 25 | 31 |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiomyopathy NOS | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Drug withdrawal syndrome | General disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
|
| Acid-base balance disorder mixed | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Feeding Disorder NOS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Food intolerance NOS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Renal impariment NOS | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Renal infarct | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Meconium aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Respiratory failure (exc neonatal) | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hypertension NOS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension NOS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Intraventricular haemorrhage NOS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pulmonary hypertension NOS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocyptopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Bradycardia NOS | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiomegaly NOS | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Pulmonary edema NOS | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia NOS | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
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| Drug withdrawn syndrome | General disorders | MedDRA | Systematic Assessment |
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| Oedema NOS | General disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Jaundice NOS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Pneumonia NOS | Infections and infestations | MedDRA | Systematic Assessment |
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| Sepsis NOS | Infections and infestations | MedDRA | Systematic Assessment |
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| Blood magnesium decreased | Investigations | MedDRA | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
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| Feeding disorder NOS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypoglycemia NOS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypertonia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Hypotonia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Oliguria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Renal impairment NOS | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Atlectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure (exc neonatal) | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Tachypnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Procedural site reaction | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Hypertension NOS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension NOS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pulmonary hypertension NOS | Vascular disorders | MedDRA | Systematic Assessment |
|
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| D011248 |
| Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |