Clinical trials: Respiratory Distress Neonatal
Respiratory Distress Syndrome, Newborn
A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the…
- Trial name
- NCT02452476
- Testing
- CHF5633, Poractant alfa
- Where
- 23 sites in United States
- Volunteers
- 123 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Distress Syndrome
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
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…
- Trial name
- NCT02636868
- Testing
- Lucinactant delivered via investigational delivery device, nCPAP
- Where
- 54 sites in United States, Canada and 6 more
- Volunteers
- 221 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome, Newborn, Pulmonary Ventilation; Newborn, Abnormal
Continuous Monitoring of Lung Ventilation
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation.
- Conditions
- Respiratory Distress Syndrome, Newborn, Pulmonary Ventilation; Newborn, Abnormal, Apnea, Respiration Disorders
- Trial name
- NCT00810186
- Where
- 3 sites in Israel
- Volunteers
- 77 people
- Sponsor
- Pneumedicare Ltd.
Respiratory Distress Syndrome, Newborn
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
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…
- Trial name
- NCT04264156
- Testing
- Lucinactant for Inhalation, nCPAP Only
- Where
- 3 sites in Poland
- Volunteers
- 12 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
A prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess…
- Trial name
- OPTI-SURF (NCT03808402)
- Where
- 29 sites in United Kingdom
- Volunteers
- 2,973 people
- Sponsor
- Chiesi UK
Fetal Hypoxia, Fetal Distress
Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE
The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy.
- Conditions
- Fetal Hypoxia, Fetal Distress, Fetal Conditions, Fetal Complications
- Trial name
- NCT06405984
- Testing
- Fetal Oxygenation Measurements
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Hyalinosis, Hyaline Membrane Disease
Biomarker for Hyaline Fibromatosis Syndrome (BioHFS)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Hyaline fibromatosis syndrome from the blood
- Conditions
- Hyalinosis, Hyaline Membrane Disease, Juvenile Hyaline Fibromatosis, Fibromatosis Hyalinica Multiplex Juvenilis
- Trial name
- BioHFS (NCT03196115)
- Where
- 3 sites in Germany, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Respiratory Distress Syndrome, Newborn
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32 weeks) in real life situation and the management of RDS.
- Trial name
- NCT01102543
- Where
- France
- Volunteers
- 972 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Neonatal Respiratory Distress
Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS).
- Trial name
- NCT03582930
- Testing
- Infasurf Aero
- Where
- 5 sites in United States
- Sponsor
- ONY
Respiratory Distress Syndrome In Premature Infants
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive…
- Trial name
- NCT02445040
- Testing
- Babylog VN500 in HFOV Mode
- Where
- 14 sites in United States
- Volunteers
- 225 people
- Sponsor
- Draeger Medical Systems, Inc.