Clinical trials: Neonatal Respiratory Distress
Neonates and Preterm Infants, Infant Respiratory Distress Syndrome
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA)…
- Conditions
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant
- Trial name
- SurfStab I (NCT07261787)
- Testing
- Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration
- Where
- Austria
- Volunteers
- 76 people
- Sponsor
- Medical University of Graz
Neonatal Respiratory Distress Syndrome, PreTerm Neonate
MINImising Total Radiation EXposure in Preterm Infants
Being born too early (preterm birth) is the leading cause of death in children world-wide. In Australia, 97% of very preterm babies who are admitted to Neonatal Intensive Care Units need breathing support after birth to survive.
- Trial name
- MINI T-Rex (NCT06975189)
- Testing
- Lung ultrasound group, Standard Care
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- Western Health, Australia
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 in Premature Infant, RDS of Prematurity
Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive…
- Conditions
- Respiratory Distress Syndrome in Premature Infant, RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Premature Birth
- Trial name
- NCT06554522
- Testing
- Surfactant
- Where
- 8 sites in Central African Republic, Ghana and 2 more
- Volunteers
- 1,512 people
- Sponsor
- Indiana University
Neonatal Respiratory Distress
Transference of Established Simulated Skills (TEST) Trial
This study aims to determine if skills learned in the simulation lab, specifically in managing mask leak during positive pressure ventilation (PPV), translate effectively to the delivery room.
- Trial name
- TEST (NCT06572033)
- Testing
- Simulation
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
The purpose of this study is to analyze the gastric fluid aspirated from the stomachs of neonates receiving routine post-delivery care to predict the need for prolonged respiratory support (>6 hours of life).
- Conditions
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant, Transient Tachypnea of the Newborn, Meconium Aspiration Syndrome
- Trial name
- NCT07344714
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Disorders
Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates
The aim of the study is to compare the non-inferiority of the Mix-safe T-piece resuscitator (intervention group) to the Neopuff T-piece resuscitator (control group) in providing respiratory assistance during the resuscitation of…
- Trial name
- NCT07422116
- Testing
- Mixsafe T piece resucitator, Standardized T Piece resuscitator
- Where
- Indonesia
- Volunteers
- 107 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Preterm Infants, Respiratory Distress Syndrome (Neonatal)
Pressure Targeting During High Flow Therapy in Premature Infants
The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants.
- Conditions
- Preterm Infants, Respiratory Distress Syndrome (Neonatal), BPD - Bronchopulmonary Dysplasia
- Trial name
- NeoMATCH (NCT07418502)
- Testing
- Pressure Targeted High Flow, CPAP
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- University of Texas at Austin
Infant, Premature, Diseases, Respiratory Distress Syndrome
Pain Assessment During Less-Invasive-Surfactant-Administration
Primary aims of the study are to evaluate the feasibility of Skin conductance (SC) measurements and its correlation to Neonatal Pain and Distress Scale (N-PASS) - scores during the Less-Invasive-Surfactant-Administration…
- Conditions
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Pain
- Trial name
- PALISA (NCT06150586)
- Testing
- Skin Conductance (SC) Measurement, Video Recording
- Where
- Switzerland
- Volunteers
- 21 people
- Sponsor
- University of Zurich
Respiratory Distress Neonatal
ADINA vs. High Flow Nasal Cannula Comparison Study
This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.
- Trial name
- NCT03171129
- Testing
- Adaptive Dynamic Inspiratory Nasal Apparatus, High flow Nasal Canula
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Loma Linda University
Neonatal Respiratory Distress
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room. Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery…
- Trial name
- VOLT (NCT05144724)
- Testing
- Volume targeted ventilation, Pressure targeted ventilation
- Where
- Canada
- Volunteers
- 52 people
- Sponsor
- University of Alberta
Premature Lungs, Respiratory Distress Syndrome
Early Caffeine and LISA Compared to Caffeine and CPAP in Preterm Infants
This study is being conducted to determine whether prophylactic administration of surfactant by the Less Invasive Surfactant Administration (LISA) method reduces the need for mechanical ventilation in the first 72 hours of life…
- Conditions
- Premature Lungs, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal
- Trial name
- CaLI (NCT04209946)
- Testing
- Less Invasive Surfactant Administration LISA, Continuous Positive Airway Pressure CPAP
- Where
- 3 sites in United States
- Volunteers
- 180 people
- Sponsor
- Sharp HealthCare
Infant, Preterm, Respiratory Distress Syndrome (Neonatal)
Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation
Current evidence suggests that noninvasive positive pressure ventilation (NIPPV) is more effective than continuous positive airway pressure (CPAP) in preventing respiratory failure in preterm infants with respiratory distress…
- Conditions
- Infant, Preterm, Respiratory Distress Syndrome (Neonatal), Chronic Lung Disease of Newborn, Respiratory Support
- Trial name
- INSPIRE (NCT07237139)
- Testing
- Electrical Impedance Tomography (EIT)
- Where
- Switzerland
- Volunteers
- 27 people
- Sponsor
- University of Zurich
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Neonatal Respiratory Distress Syndrome
To Investigate the Effect of Pulmonary Surfactant With Different Inspired Oxygen Concentrations on the Clinical Outcomes of Very Preterm Infants Under Non-invasive Assisted Ventilation
A prospective multicenter randomized controlled study was conducted. Eligible very preterm infants with a gestational age of <32 weeks were enrolled.
- Trial name
- NCT07235345
- Testing
- According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Xu Falin
Respiratory Distress Syndrome (Neonatal)
Open-label Randomized Controlled Trial of Two Protocols for Weaning From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome Admitted in the NICU of Mansoura University Children Hospital
Our study is a randomized controlled trial that compares two weaning protocols of preterm infants with respiratory distress syndrome who are ventilated on high frequency oscillatory ventilation in order to establish the best…
- Trial name
- NCT07202299
- Testing
- HFOV weaning protocol 1, HFOV weaning protocol 2
- Where
- Egypt
- Volunteers
- 110 people
- Sponsor
- Mansoura University Children Hospital
Respiratory Distress Neonatal, Noninvasive Ventilation
Comparison of the Silverman-Andersen Score and the Downes Score
This study aimed to compare the Silverman-Andersen score and the Downes score in predicting noninvasive ventilation (NIPPV) failure in preterm and term infants who received NIPPV support due to postnatal respiratory distress, as…
- Conditions
- Respiratory Distress Neonatal, Noninvasive Ventilation, Intubation, Scoring Systems
- Trial name
- CSASDS (NCT07183956)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 220 people
- Sponsor
- Muğla Sıtkı Koçman University
Preterm Birth, Premature
Comparison of the Acute Effects of Chest Physiotherapy Methods Applied in Different Positions in Preterm Newborns
Infants in the neonatal intensive care unit (NICU) may be lost due to risks such as being sensitive, frequent exposure to birth complications and being prone to infection.
- Conditions
- Preterm Birth, Premature, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
- Trial name
- therapy (NCT05036603)
- Testing
- chest physiotherapy
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Sanko University
Neonatal Respiratory Distress
Study of PREMEdication Before Laryngoscopy in Neonates in France
This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify…
- Trial name
- SUPREMEneo (NCT06356909)
- Testing
- Survey of sedo-analgesia practices before laryngoscopy
- Where
- France
- Volunteers
- 741 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Respiratory Distress Syndrome, Neonatal Death
Implementing LISA Surfactant in Nigeria
Implement surfactant (BLES®) replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born…
- Trial name
- NCT05714865
- Testing
- Surfactant
- Where
- 6 sites in Nigeria
- Volunteers
- 349 people
- Sponsor
- Indiana University