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The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Respiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.
The purpose of this study is to investigate the safety and efficacy of lucinactant for inhalation in preterm neonates 26 to 32 completed weeks post-menstrual age (PMA). Efficacy and safety are based on clinical evaluations. The endpoints specified are similar to those in Protocols 03-CL-1201 and 03-CL-1401 to allow for potential comparison and pooling of results.
The objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, compared to nCPAP alone, in preterm neonates with RDS, as assessed by the time to and incidence of respiratory failure and/or death due to RDS over the first 72 hours of life, the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks PMA, and change in physiologic parameters (FiO2 and PCO2) over the first 72 hours of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerosolized lucinactant (low dose) | Experimental | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. |
|
| Aerosolized lucinactant (high dose) | Experimental | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. |
|
| nasal CPAP | Active Comparator | nCPAP alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucinactant delivered via investigational delivery device | Drug | Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS) | Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Respiratory Failure or Death Due to RDS | Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria | 72 hours |
| Time to nCPAP Failure | Time from birth to nCPAP Failure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
A heart rate that cannot be stabilized above 100 beats per minute (bpm) within 5 minutes of birth
Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered manually or mechanically through any patient interface
A 5 minute Apgar score < 5
Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP, diagnosed antenatally or immediately after birth
Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function (e.g. congenital heart disease, hydrops fetalis or congenital infection)
A known or suspected chromosomal abnormality or syndrome
Premature rupture of membranes (PROM) > 3 weeks
Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
A need for intubation and/or mechanical ventilation at any time before enrollment into the study
The administration (or plan for administration) of any the following:
Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema (PIE)) on the baseline chest radiograph
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| Name | Affiliation | Role |
|---|---|---|
| Steven Simonson, MD | Windtree Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Univ. of Arkansas Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aerosolized Lucinactant (40 mg TPL/kg) | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) nCPAP: Nasal CPAP |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2017 | Feb 7, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| nCPAP | Drug | Nasal CPAP |
|
| 72 hours |
| Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling | The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred. | 72 hours |
| Incidence of Respiratory Failure or Death Due to RDS | Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria | 28 days |
| Number of Participants With Bronchopulmonary Dysplasia (BPD) | Summarizes the number of participants with BPD or alive without BPD | 36 weeks post-menstrual age (PMA) |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | United States |
| Christiana Care Health System | Newark | Delaware | 19713 | United States |
| University of Miami Holtz Children's Hospital | Miami | Florida | 33136 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Brody School of Medicine at ECU | Greenville | North Carolina | 27834 | United States |
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | United States |
| Case Western Reserve University (Rainbow Babies Hosp.) | Cleveland | Ohio | 44106 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Cook Children's Hospital | Fort Worth | Texas | 76104 | United States |
| Texas Health Harris Methodist Hospital | Fort Worth | Texas | 76104 | United States |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Montreal Children's Hospital | Montreal | Quebec | H3H 1P3 | Canada |
| Sainte Justine Hospital | Montreal | Quebec | H3T 1C5 | Canada |
| Hospital Dr Sotero Del Rio | Santiago | Region-MetropolitanadeSantiago | 8207257 | Chile |
| Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente | Concepción | 4070038 | Chile |
| Hospital San Jose | Santiago | 3330 | Chile |
| Clinica Alamena de Santiago | Santiago | 7650568 | Chile |
| Hospital Santiago Oriente Dr Luis Tisné Brousse | Santiago | 7980378 | Chile |
| Hospital Clinico de la Pontificia Universidad Catolica de Chile | Santiago | 8330024 | Chile |
| Hospital San Juan de Dios | Santiago | 8350488 | Chile |
| Fundacion Hospitalaria San Vicente de Paul | Medellín | Antioquia | 050010 | Colombia |
| Hospital General de Medellin | Medellín | Antioquia | 050015 | Colombia |
| Fundacion Valle Del Lili | Cali | Valle del Cauca Department | 760032 | Colombia |
| Semmelweis Egyetem | Budapest | 1082 | Hungary |
| Csolnoky Ferenc Korhaz | Debrecen | 4032 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | H-4012 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato | Miskolc | 3526 | Hungary |
| Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz | Nyíregyháza | H-4400 | Hungary |
| Cork University Hospital | Cork | T12 YN60 | Ireland |
| Mid-Western Regional Hospital Limerick | Limerick | Ireland |
| Erasmus Medical Center | Rotterdam | 3000 CB | Netherlands |
| Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii | Poznan | Greater Poland Voivodeship | 60-535 | Poland |
| S.U. nr2im. Dr. Jana Biziela Oddzial Kliniczny N. W. Z. Intensywna Terapia Noworodka wraz z Wgjazdowy m Zespolem N | Bydgoszcz | Kujawsko-pomorksie | 85-168 | Poland |
| SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Neonatologii | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Lower Silesian Voivodeship | 50-556 | Poland |
| Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii | Warsaw | Masovian Voivodeship | 00-315 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-402 | Poland |
| Szpital Spegialistycszny nr 2 w Bytomia Oddzial Noworodkow Blok V | Bytom | Silesian Voivodeship | 41-902 | Poland |
| Samodzielny Publiczny Specjalistczny Zaklad Opieki Zdrowotnej Zdroje | Szczecin | West Pomeranian Voivodeship | 70-780 | Poland |
| Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii | Lodz | Łódź Voivodeship | 93-338 | Poland |
| FG001 | Aerosolized Lucinactant (80 mg TPL/kg) | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) nCPAP: Nasal CPAP |
| FG002 | nCPAP Only | nCPAP alone nCPAP: Nasal CPAP |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Randomized Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aerosolized Lucinactant (40 mg TPL/kg) | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) nCPAP: Nasal CPAP |
| BG001 | Aerosolized Lucinactant (80 mg TPL/kg) | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) nCPAP: Nasal CPAP |
| BG002 | nCPAP Only | nCPAP alone nCPAP: Nasal CPAP |
| BG003 | 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, Customized | Mean | Standard Deviation | weeks post menstrual age |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Birth Weight | Mean | Standard Deviation | grams |
| |||||||||||||||
| Ruptured Membranes | Count of Participants | Participants |
| ||||||||||||||||
| Chorioamnionitis | Count of Participants | Participants |
| ||||||||||||||||
| Steroid Use, Maternal | Count of Participants | Participants |
| ||||||||||||||||
| Mode of Delivery | Count of Participants | Participants |
| ||||||||||||||||
| Birth Status | Count of Participants | Participants |
| ||||||||||||||||
| Appearance, Pulse, Grimace, Activity, and Respiration (Apgar) Score at One Minute | In the test, five things are used to check a baby's health at 1 minutes after birth. Each is scored on a scale of 0 to 2, with 2 being the best score: Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort) The individual scores are summed to determine the total score. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| Apgar Score at Five Minutes | In the test, five things are used to check a baby's health at 5 minutes after birth. Each is scored on a scale of 0 to 2, with 2 being the best score: Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort) The individual scores are summed to determine the total score. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| Congenital Anomaly | Count of Participants | 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 Failure or Death Due to Respiratory Distress Syndrome (RDS) | Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure | Modified Intent-to-Treat; randomized subjects who received study treatment | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Respiratory Failure or Death Due to RDS | Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria | Modified Intent-to-Treat Population without Treatment Interruptions | Posted | Count of Participants | Participants | 72 hours |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to nCPAP Failure | Time from birth to nCPAP Failure | Modified Intent-to-Treat; randomized participants who received study treatment | Posted | Least Squares Mean | Standard Error | hours | 72 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling | The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred. | Modified Intent-to-Treat | Posted | Count of Participants | Participants | 72 hours |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Respiratory Failure or Death Due to RDS | Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria | Modified Intent-to-Treat | Posted | Count of Participants | Participants | 28 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Bronchopulmonary Dysplasia (BPD) | Summarizes the number of participants with BPD or alive without BPD | Modified Intent-to-Treat | Posted | Count of Participants | Participants | 36 weeks post-menstrual age (PMA) |
|
Enrollment to 36 weeks post-menstrual age
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aerosolized Lucinactant (40 mg TPL/kg) | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) nCPAP: Nasal CPAP | 0 | 70 | 16 | 70 | 65 | 70 |
| EG001 | Aerosolized Lucinactant (80 mg TPL/kg) | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) nCPAP: Nasal CPAP | 1 | 72 | 14 | 72 | 69 | 72 |
| EG002 | nCPAP Only | nCPAP alone nCPAP: Nasal CPAP | 2 | 71 | 20 | 71 | 66 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Patent ductus arteriosus | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Coarctation of the aorta | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Neurological infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nocosomial infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Septic embolus | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intraventricular haemorrhage neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Necrotising enterocolitis neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Apnoea neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary interstitial emphysema syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary oedema neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Coagulation disorder neonatal | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Patent ductus arteriosus | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Feeding intolerance | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Agitation neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Bradycardia neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Intraventricular haemorrhage neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Retinopathy of prematurity | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Weight decrease neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Apnoea neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atelectasis neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchopulmonaria dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neonatal tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
Clogging of a in-line filter led to a higher number of treatment interruptions than expected. This primarily affected one batch of supplies that were, by chance, predominantly used in European sites.
The Steering Committee is responsible for publications, including who will be authoring publications. The sponsor has the right to review publications before they are published and can provide suggested edits, but cannot require changes or prevent publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director of Biostatistics & Data Management | Windtree Therapeutics, Inc. | 215-488-9477 | psimmons@windtreetx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2017 | Feb 7, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2016 | Feb 7, 2020 | ICF_002.pdf |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C502722 | lucinactant |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Colombia |
|
| Netherlands |
|
| Hungary |
|
| United States |
|
| Ireland |
|
| Poland |
|
| Chile |
|
| Artificial |
|
| No |
|
| No Steroids |
|
| Cesarean Section |
|
| Multiple Birth |
|
| No |
|
Null hypothesis of no difference between treatments |
| Regression, Logistic |
Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model |
| 0.360 |
a priori threshold of statistical significance set at 0.05 |
| Superiority |
| Null hypothesis of no difference between treatments | Regression, Logistic | Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model | 0.461 | a priori threshold of statistical significance set at 0.05 | Superiority |
|
|
|
| Units | Counts |
|---|---|
| Participants |
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nCPAP alone
nCPAP: Nasal CPAP
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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