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Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).
Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucinactant | Experimental | SURFAXIN® (lucinactant) for intratracheal instillation |
|
| Sham Air | Sham Comparator | Sham air (placebo) instillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucinactant | Drug | Slow intra-tracheal instillation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Mechanical Ventilation Through 14 Days | Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days. | Up to 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal Thomas, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Adrienne Randolph, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call for information | Warrington | Pennsylvania | 18976 | United States | ||
| Call for Information |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22791092 | Derived | Thomas NJ, Guardia CG, Moya FR, Cheifetz IM, Markovitz B, Cruces P, Barton P, Segal R, Simmons P, Randolph AG; PALISI Network. A pilot, randomized, controlled clinical trial of lucinactant, a peptide-containing synthetic surfactant, in infants with acute hypoxemic respiratory failure. Pediatr Crit Care Med. 2012 Nov;13(6):646-53. doi: 10.1097/PCC.0b013e3182517bec. |
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Subjects were enrolled at 24 hospitals in the United States and Chile from 04 June, 2007 to 23 March, 2010. Last subject's last visit occurred on 05 April, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lucinactant | KLâ‚„Surfactant (lucinactant) endotracheal instillation |
| FG001 | Sham Air | Sham air (placebo) instillation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lucinactant | KLâ‚„Surfactant (lucinactant) endotracheal instillation |
| BG001 | Sham Air | Sham air (placebo) instillation |
| 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 | Duration of Mechanical Ventilation Through 14 Days | Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days. | The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses. | Posted | Least Squares Mean | 95% Confidence Interval | days | Up to 14 Days |
|
14 days from randomization or until resolution of adverse events.
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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 | KLâ‚„Surfactant (lucinactant) endotracheal instillation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neal J. Thomas | Penn State Children's Hospital | 717-531-5337 | nthomas@hmc.psu.edu |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C502722 | lucinactant |
| D013501 | Surface-Active Agents |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Sham Comparator | Other | Slow intra-tracheal instillation |
|
|
| Concepción |
| Chile |
| Call For Information | Santiago | Chile |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Sham air (placebo) instillation |
|
|
| Secondary | Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses. | Posted | Least Squares Mean | 95% Confidence Interval | days | Up to 14 days |
|
|
|
| 20 |
| 84 |
| 65 |
| 84 |
| EG001 | Sham Air | Sham air (placebo) instillation | 14 | 81 | 62 | 81 |
| Bradycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Coarctation of the aorta | Congenital, familial and genetic disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pertussis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Drug withdrawal syndrome | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
First publication must be joint, multicenter publication in conjunction with a presentation. Following multicenter publication, proposed publications or presentations must be submitted to sponsor 30 days in advance. In the event of an objection by sponsor, PI agrees to delay the publication or presentation until modifications or revisions have been made to protect Sponsor's patent rights, copyrights, or proprietary rights.
| Duration of Supplemental Oxygen |
|
| Duration of Hospitalization |
|