Clinical trials: Respiratory Control in Premature Infants
Ventilator-Induced Lung Injury, Respiratory Distress Syndrome
Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
The purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator…
- Conditions
- Ventilator-Induced Lung Injury, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Preterm Infant
- Trial name
- MIDAS (NCT03231735)
- Testing
- Mid frequency ventilation, Standard frequency ventilation
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Alabama at Birmingham
Newborn Morbidity, Respiratory Failure
Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC
Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured.
- Conditions
- Newborn Morbidity, Respiratory Failure, Bronchopulmonary Dysplasia, Mechanical Ventilation Complication
- Trial name
- NCT04191239
- Testing
- GE ventilator with two different modes
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- Ankara City Hospital Bilkent
Respiratory Distress Syndrome, Preterm Infant
Nasal High Frequency Oscillation Ventilation(NHFOV) for Respiratory Distress Syndrome
In very preterm infants with severe respiratory distress syndrome(RDS), invasive ventilation(IV) , besides nasal continuous positive airway pressure (NCPAP) and early/selective pulmonary surfactant administration, is one key…
- Trial name
- NHFOV (NCT03140891)
- Testing
- NHFOV, NCPAP
- Where
- China
- Volunteers
- 206 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Apnea, Infant, Premature
Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.
Very premature infants uniformly do not have mature functioning lungs to breathe well nor mature regulation mechanisms to breathe regularly. Assistance with a mechanical respirator is common.
- Conditions
- Apnea, Infant, Premature, Bronchopulmonary Dysplasia
- Trial name
- NCT00188968
- Testing
- Nasal Continuous Positive Airway Pressure, Synchronized Nasal Positive Pressure Ventilation
- Where
- 2 sites in Canada
- Volunteers
- 48 people
- Sponsor
- University of Manitoba
Neonatal Respiratory Distress Related Conditions, Neonatal Respiratory Failure
Automated Versus Manual Control Of Oxygen For Preterm Infants On Continuous Positive Airway Pressure In Nigeria
One in ten babies are born preterm (<37 weeks gestation) globally. Complications of prematurity are the leading cause of death in children under 5 years, with the highest mortality rate in Sub-Saharan Africa (SSA).
- Conditions
- Neonatal Respiratory Distress Related Conditions, Neonatal Respiratory Failure, Prematurity, Oxygen Toxicity
- Trial name
- NCT05508308
- Testing
- OxyMate, Manual oxygen control
- Where
- 2 sites in Nigeria
- Volunteers
- 49 people
- Sponsor
- Murdoch Childrens Research Institute
Premature Birth, Respiratory Insufficiency
Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP)
Continuous positive airway pressure (CPAP) has been used successfully to promote extubation in the premature infant population. The two methods of CPAP to be examined are currently used by many institutions, yet no study has…
- Trial name
- NCT00187434
- Testing
- Infant Flow System, Bubble CPAP
- Where
- Canada
- Volunteers
- 76 people
- Sponsor
- Sunnybrook Health Sciences Centre
Prematurity, Respiratory Distress Syndrome
Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome
The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal…
- Trial name
- NCT00821119
- Testing
- nasal intermittent positive pressure ventilation
- Where
- 2 sites in Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Respiratory Tract Infection, Respiratory Syncytial Virus
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational…
- Trial name
- NCT03524118
- Testing
- Clesrovimab
- Where
- 34 sites in United States, Chile and 4 more
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Bronchopulmonary Dysplasia (BPD), ELGAN (22-28SA)
Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants
This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth.
- Trial name
- HULC-2 (NCT07058025)
- Testing
- Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
- Where
- 8 sites in Canada
- Volunteers
- 168 people
- Sponsor
- Ottawa Hospital Research Institute
Bronchopulmonary Dysplasia
TINN2: Treat Infection in NeoNates 2
The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.
- Trial name
- TINN2 (NCT02282176)
- Testing
- Azithromycin
- Where
- 16 sites in Belgium, France and 7 more
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
RSV Infections, RSV Immunisation
A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.
Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too…
- Conditions
- RSV Infections, RSV Immunisation, Preterm Labour
- Trial name
- NCT06955728
- Testing
- Vaccine
- Where
- 11 sites in Ghana, Kenya and 2 more
- Volunteers
- 13,000 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Respiratory Control in Premature Infants
Prematurity-Related Ventilatory Control
The purpose of this research study is to improve our understanding of unstable breathing and heart blood flow patterns seen in premature infants.
- Trial name
- PreVent (NCT03464396)
- Testing
- Bedside Physiology study, Carotid Body Function Test, Room Air Challenge
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- Washington University School of Medicine
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Motor Delay, Premature Birth
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials.
- Conditions
- Motor Delay, Premature Birth, Intraventricular Hemorrhage, Hypoxic-Ischemic Encephalopathy
- Trial name
- NCT05568264
- Testing
- Physical Therapy intervention
- Where
- 3 sites in United States
- Volunteers
- 222 people
- Sponsor
- Shirley Ryan AbilityLab
Kangaroo-Mother Care, Preterm Infants
Early Kangaroo Care vs. Standard Neonatal Practices: Impact on Survival and Outcomes in Preterm Infants
This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams…
- Trial name
- NCT06707376
- Testing
- Early Kangaroo Mother Care
- Where
- Egypt
- Volunteers
- 240 people
- Sponsor
- Jouf University
Respiratory Distress Syndrome (RDS), Newborn
Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
The goal of this clinical trial is to learn if nasal high frequency oscillatory ventilation (nHFOV) works no worse than nasal intermittent mandatory ventilation (NIMV) as early breathing support.
- Conditions
- Respiratory Distress Syndrome (RDS), Newborn, Premature Birth
- Trial name
- NOV-RDS (NCT07837141)
- Testing
- Noninvasive High Frequency Oscillatory Ventilation, Nasal Intermittent Mandatory Ventilation
- Where
- Pakistan
- Volunteers
- 158 people
- Sponsor
- Aga Khan University
Apnea of Prematurity
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after…
- Trial name
- MoCHA (NCT03340727)
- Testing
- Caffeine Citrate
- Where
- 16 sites in United States
- Volunteers
- 827 people
- Sponsor
- NICHD Neonatal Research Network
Pre-Term, Respiratory Disease
Closed-loop Oxygen Control in Ventilated Infants Born at or Near Term
Ventilated neonates frequently require supplementary oxygen to allow for adequate oxygen delivery to the tissues and normal cell metabolism.
- Trial name
- NCT05017727
- Testing
- Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- King's College Hospital NHS Trust
Pre-Term, Respiratory Distress Syndrome, Newborn
NeO2Matic-Pilot Trial
The main goal of this trial is to test if: automated adjustment of supplemental oxygen to preterm infants in noninvasive respiratory support based on feedback from a measurement of blood-oxygen saturation results in more stable…
- Conditions
- Pre-Term, Respiratory Distress Syndrome, Newborn, Retinopathy of Prematurity, Bronchopulmonary Dysplasia
- Trial name
- NEO2MATIC (NCT05629910)
- Testing
- O2Matic
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Respiratory Syncytial Virus (RSV)
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16…
- Trial name
- NCT07363837
- Testing
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products