Clinical trials: RDS of Prematurity
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks…
- Trial name
- NCT02074059
- Testing
- Lucinactant for Inhalation, nCPAP alone
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Windtree Therapeutics
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
Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the…
- Trial name
- NEOSURF (NCT02834624)
- Testing
- Poractant alfa, calfactant
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Missouri-Columbia
Respiratory Distress Syndrome
Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb.
- Trial name
- NCT02392806
- Testing
- Bubble CPAP- BabiPlus, Respiralogics, Bubble CPAP- B&B Bubbler, B&B Medical devices
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Marya Strand, MD
Prematurity, Respiratory Distress Syndrome
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates.
- Conditions
- Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
- Trial name
- CAST (NCT00767039)
- Testing
- Survanta (beractant), Curosurf (poractant)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Alan Fujii
Respiratory Distress Syndrome, Newborn
Comparison of CPAP Machines With Reusable vs Disposable Circuits
The study aims to assess the basic functionality of a newly designed CPAP machine with reusable circuits to existing machines with disposable circuits, for treatment of newborn infants diagnosed with respiratory distress…
- Trial name
- NCT03121612
- Testing
- CPAP
- Where
- India
- Volunteers
- 51 people
- Sponsor
- Medical Technology Transfer and Services Hong Kong Ltd
Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome
The Budesonide in Babies (BiB) Trial
This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal
- Trial name
- BiB (NCT04545866)
- Testing
- budesonide (Pulmicort nebulizing suspension)., surfactant (poractant alfa;Curosurf)
- Where
- 19 sites in United States
- Volunteers
- 642 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome, Newborn
Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome
In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be randomized to standard delivery of…
- Trial name
- NCT02164734
- Testing
- Endotracheal intubation, Laryngeal mask airway, remifentanil
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- Albany Medical College
Infant, Premature, Diseases, Infant, Newborn, Diseases
Pulmonary Function Using Non-invasive Forced Oscillometry
The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of…
- Conditions
- Infant, Premature, Diseases, Infant, Newborn, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Newborn
- Trial name
- PUFFOR (NCT03346343)
- Testing
- Non-invasive forced airway oscillometry
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Transient Tachypnea of the Newborn
High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
The primary objective is to determine whether High Flow Nasal Cannula (HFNC) is a superior respiratory modality for neonates ≥36 weeks with transient tachypnea of the newborn (TTN) when compared to the standard of care modality…
- Trial name
- NCT01270581
- Testing
- High Flow Nasal Cannula, Bubble Nasal CPAP
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
- Trial name
- TOLSURFPilot (NCT00569530)
- Testing
- Infasurf (ONY Inc.)
- Where
- 9 sites in United States
- Volunteers
- 85 people
- Sponsor
- Roberta Ballard
RDS of Prematurity
NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)
The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).
- Trial name
- NIV (NCT02259400)
- Testing
- NSIPPV, BiPAP
- Volunteers
- 280 people
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
NHFOV as Primary Support in Very Preterm Infants With RDS
This will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in China.
- Trial name
- NCT05141435
- Testing
- infants receive primary non-invasive respiratory support by mean of nCPAP, infants receive primary non-invasive respiratory support by mean of NHFOV
- Where
- 3 sites in China
- Volunteers
- 360 people
- Sponsor
- Jiulongpo No.1 People's Hospital
Respiratory Distress Syndrome
Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA
This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS…
- Trial name
- NCT02528318
- Testing
- Lucinactant for inhalation, nCPAP alone
- Where
- 20 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Windtree Therapeutics
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, Bronchopulmonary Dysplasia
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
The primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (CPAP), and then randomized to two…
- Trial name
- NCT02249143
- Testing
- CPAP and room air
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Oregon Health and Science University
Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection.
- Trial name
- NCT01941745
- Testing
- Half normal saline, Low Dose rhCC10, High dose rhCC10
- Where
- 3 sites in United States
- Volunteers
- 88 people
- Sponsor
- Tufts Medical Center
Transient Tachypnea of the Newborn
Fluid Management in Transient Tachypnea of the Newborn
Transient tachypnea of the newborn (TTN) is a diagnosis given to infants born between 34 and 42 weeks gestation who develop difficulty breathing during the first days of life when no specific cause of the breathing difficulty can…
- Trial name
- NCT01225029
- Testing
- Amount of total fluids
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Icahn School of Medicine at Mount Sinai