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Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerosolized Calfactant | Experimental |
|
|
| Usual Care | No Intervention | There will be no protocol driven interventions in the usual care group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosolized Calfactant | Drug | Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intubation and Instillation of Liquid Surfactant | Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Support Requirements | Difference of Respiratory support at 28 days | 28 days |
| Air Leak | Percent of at risk subjects with air leak at any time |
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Inclusion Criteria:
RDS Patients
NICU patient, ≥1hour of age and <24 hours of age.
Clinical diagnosis of RDS, with or without chest X-ray data.
Inspired oxygen ≥21% to maintain adequate oxygen saturation.
Not intubated
Requiring:
Exclusion Criteria:
Congenital anomaly limiting care options or requiring early surgery.
Cardiopulmonary decompensation.
Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
Acute hypoxic encephalopathy with or without seizures.
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| Name | Affiliation | Role |
|---|---|---|
| James Cummings, MD | Albany Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA Children's & Women's Hospital | Mobile | Alabama | 36604 | United States | ||
| Banner - University Medical Center Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33060258 | Derived | Cummings JJ, Gerday E, Minton S, Katheria A, Albert G, Flores-Torres J, Famuyide M, Lampland A, Guthrie S, Kuehn D, Weitkamp JH, Fort P, Abu Jawdeh EG, Ryan RM, Martin GC, Swanson JR, Mulrooney N, Eyal F, Gerstmann D, Kumar P, Wilding GE, Egan EA; AERO-02 STUDY INVESTIGATORS. Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial. Pediatrics. 2020 Nov;146(5):e20193967. doi: 10.1542/peds.2019-3967. Epub 2020 Oct 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aerosolized Calfactant |
Aerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. Solarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2020 |
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| Solarys | Device | Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. |
|
| 28 days |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Sharp Mary Birch Hospital for Women & Newborns | San Diego | California | 92123 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Adventist Healthcare System, Florida Hospital | Orlando | Florida | 32803 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| University of South Florida, Tampa general | Tampa | Florida | 33606 | United States |
| Columbus Regional Hospital | Columbus | Georgia | 31904 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Kentucky Children's Hospital, University of Kentucky Medical Center | Lexington | Kentucky | 40506 | United States |
| Children's Hospital and Clinics | Minneapolis | Minnesota | 55404 | United States |
| Children's Hospital Minnesota | Saint Paul | Minnesota | 55102 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Sisters of Charity Hospital | Buffalo | New York | 14214 | United States |
| Pitt County Memorial Hospital | Greenville | North Carolina | 27835 | United States |
| The Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Jackson-Madison County General Hospital | Jackson | Tennessee | 38301 | United States |
| Vanderbilt university Medical Center | Nashville | Tennessee | 37232 | United States |
| North central Baptist Hospital | San Antonio | Texas | 78258 | United States |
| Timpanogos Regional Medical Center | Orem | Utah | 84057 | United States |
| Utah Valley Hospital | Provo | Utah | 84604 | United States |
| University of Virgina Medical Center | Charlottesville | Virginia | 22903 | United States |
| FG001 | Usual Care | There will be no protocol driven interventions in the usual care group. |
| COMPLETED |
|
| NOT COMPLETED |
|
477 were randomized into the two cohorts between April 2017 and June 2018. Having reached our sample size target for cohort 1, further enrollment into cohort 2 was discontinued.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aerosolized Calfactant |
Aerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. Solarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. |
| BG001 | Usual Care | There will be no protocol driven interventions in the usual care group. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | weeks |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | 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 | Intubation and Instillation of Liquid Surfactant | Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours. | All enrolled patients. | Posted | Count of Participants | Participants | 72 hours |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Respiratory Support Requirements | Difference of Respiratory support at 28 days | Posted | Count of Participants | Participants | 28 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Air Leak | Percent of at risk subjects with air leak at any time | All Enrolled | Posted | Count of Participants | Participants | 28 days |
|
|
Birth to 28 days or discharge, whichever came first.
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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 | Aerosolized Calfactant | Aerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. Solarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. | 0 | 241 | 13 | 241 | 225 | 241 |
| EG001 | Usual Care | There will be no protocol driven interventions in the usual care group. | 1 | 236 | 14 | 236 | 219 | 236 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Air Leak | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Patent ductus arteriosus | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Spontaneous intestinal perforation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Necrotizing enterocolitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Intraventricular hemorrhage, Grade IV | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Periventricular leukomalacia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Primary pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pink colored oral discharge secretion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary Hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Polycythemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Patent ductus arteriosus | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypocalcemia | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypophosphatemia | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Retinopathy of prematurity | Eye disorders | MedDRA 21.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Emesis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Feeding Intolerance | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Gastroesophageal reflux | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Necrotizing enterocolitis neonatal | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Unspecified nutritional deficiency | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Alkaline phosphatase increase | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypochloremia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Apnea | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Intraventricular hemorrhage grade I | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Intraventricular hemorrhage grade II | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypoxemia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pulmonary interstitial emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Tachypnea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diaper Rash | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypovolemia | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Cummings, MD | Ony Biotech | 7166369096 | jcummings@onybiotech.com |
| Jul 6, 2023 |
| Prot_SAP_000.pdf |
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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 |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C117342 | calfactant |
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| Between 18 and 65 years |
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| >=65 years |
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