Respiratory Distress Syndrome, Newborn Clinical Trial
Official title:
A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation Versus nCPAP Alone in Preterm Neonates 26 to 32 Weeks Gestational Age With RDS
Verified date | April 2023 |
Source | Windtree Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory failure and/or death due to RDS in the first 72 hours and 28 days of life. Half of the subjects will receive lucinactant for inhalation and half will receive standard of care (nCPAP alone).
Status | Terminated |
Enrollment | 12 |
Est. completion date | March 28, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Minutes to 6 Hours |
Eligibility | Inclusion Criteria: - Signed ICF from legally authorized representative. - Gestational age: 26 to 32+6 weeks PMA. - Successful implementation of non-invasive support or ventilation within 30 minutes after birth. - Spontaneous breathing. - Investigator determination of RDS. A chest x-ray should be obtained before treatment to confirm the diagnosis. - Within the first 6 hours after birth, requires an nCPAP of 5 to 7 cm H2O that is clinically indicated for at least 15 minutes with an FiO2 > 0.25 to = 0.35 to maintain SpO2 of 90% to 95%. Exclusion Criteria: - A heart rate that cannot be stabilized above 100 bpm within 5 minutes of birth. - Recurrent episodes of apnea requiring positive pressure ventilation. - A 5 minute Apgar score < 5. - Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP. - Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function. - A known or suspected chromosomal abnormality or syndrome. - Premature rupture of membranes > 3 weeks. - Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis. - A need for intubation and/or invasive mechanical ventilation at any time before enrollment into the study. - The administration (or plan for administration) of another investigational agent or investigational medical device, any other surfactant agent, or systemic corticosteroids. - Presence of air leak on the baseline chest radiograph or diagnosed via ultrasound or illumination. |
Country | Name | City | State |
---|---|---|---|
Poland | Szpital Specjalistyczny nr 2 w Bytomiu Oddzial Noworodkow Blok Va | Bytom | |
Poland | Ginekologiczno-Polozniczy Szpital Kliniczny Uniwewersytetu Medycznego im. Karola Marcinkowskiego | Poznan | |
Poland | Samodzielny Publiczny Spcjalistyczny Zaklad Opieki Zdrowotnej "Zdroje", Oddzial Noworodkow | Szczecin |
Lead Sponsor | Collaborator |
---|---|
Windtree Therapeutics |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Respiratory Failure or Death | Number of participants with respiratory failure due to RDS or death. Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration | 28 days of life | |
Secondary | Number With BPD | Number of participants with bronchopulmonary dysplasia (BPD) | 36 weeks post-menstrual age (PMA) | |
Secondary | Mortality | All-cause mortality | 36 weeks PMA or 28 days of life (whichever is later) | |
Secondary | Number of Participants With Common Complications of Prematurity | Number of participants with complications including intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, apnea, necrotizing enterocolitis, patent ductus arteriosus, acquired sepsis, and retinopathy of prematurity. | 36 weeks PMA |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01206946 -
Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants
|
Phase 2 | |
Completed |
NCT00739115 -
The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study
|
N/A | |
Terminated |
NCT00486395 -
Will CPAP Reduce Length Of Respiratory Support In Premature Infants?
|
Phase 3 | |
Completed |
NCT01242462 -
Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT02050971 -
Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
|
Phase 1 | |
Completed |
NCT00486850 -
Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress
|
Phase 4 | |
Terminated |
NCT00005776 -
Inhaled Nitric Oxide Study for Respiratory Failure in Newborns
|
Phase 3 | |
Completed |
NCT04500353 -
Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial
|
N/A | |
Completed |
NCT05796128 -
NIPPV vs.nCPAP During LISA Procedure
|
N/A | |
Withdrawn |
NCT02835209 -
Positioning During SBT in NICU Infants
|
N/A | |
Terminated |
NCT01467076 -
Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
|
Phase 2 | |
Completed |
NCT00556738 -
Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn
|
N/A | |
Completed |
NCT00828243 -
Genetic Regulation of Surfactant Deficiency
|
||
Not yet recruiting |
NCT05594030 -
Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
|
||
Completed |
NCT02332304 -
Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
|
Phase 3 | |
Withdrawn |
NCT00598429 -
Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure
|
Phase 2 | |
Completed |
NCT04137783 -
ABCA3 Gene and RDS in Late Preterm and Term Infants
|
||
Completed |
NCT01941524 -
Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
|
Phase 4 | |
Completed |
NCT01102543 -
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
|
N/A | |
Completed |
NCT00501982 -
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
|
Phase 4 |