Clinical trials: Ventilator Lung; Newborn
Bronchopulmonary Dysplasia, Encephalomalacia
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
- Conditions
- Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth
- Trial name
- NCT00167544
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Nationwide Children's Hospital
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Pulmonary Disease
Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia
Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will: 1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death 2.
- Trial name
- NO-BPD (NCT01503801)
- Testing
- Nitric Oxide, respiratory support
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Fudan University
Bronchopulmonary Dysplasia (BPD)
Continued Pressure for Alveolar Protection (CPAP Trial)
The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at…
- Trial name
- CPAP (NCT07417111)
- Testing
- CPAP, Nasal Cannula
- Where
- 15 sites in United States
- Volunteers
- 860 people
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia
Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants
At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed to support its adoption as a standard care…
- Trial name
- NCT02475434
- Testing
- Cream Supplement group
- Where
- 8 sites in United States, Austria
- Volunteers
- 210 people
- Sponsor
- Baylor College of Medicine
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Infant, Premature, Diseases, Respiratory Insufficiency Syndrome of Newborn
Impact of CPAP Level on V/Q Mismatch in Premature Infants
Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas of the lung that are open for gas exchange do…
- Trial name
- NCT02983825
- Testing
- Continuous positive airway pressure (CPAP); level changes
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Children's Hospital of Philadelphia
Bronchopulmonary Dysplasia
Preservation of Blood in Extremely Preterm Infants
Current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine.
- Trial name
- LIM (NCT04239690)
- Testing
- Micromethods for blood sample analysis
- Where
- Sweden
- Volunteers
- 201 people
- Sponsor
- David Ley
Respiratory Distress Syndrome, Chronic Lung Disease of Prematurity
Prevention of Chronic Lung Disease (CLD) in Preterm Infants
Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success.
- Trial name
- NCT00883532
- Testing
- budesonide
- Where
- China
- Volunteers
- 300 people
- Sponsor
- China Medical University, China
Premature Birth, Respiratory Distress Syndrome
Non-invasive Ventilation in Preterm Infants
This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional.
- Conditions
- Premature Birth, Respiratory Distress Syndrome, Ventilator Lung; Newborn
- Trial name
- NCT05987800
- Testing
- Titration procedure, Electrical impedance tomography, Lung and diaphragm ultrasound
- Where
- Belgium
- Volunteers
- 136 people
- Sponsor
- Universitair Ziekenhuis Brussel
Bronchopulmonary Dysplasia
Clinic Features and Outcome of BPD (SGBPD)
This study described the perinatal high-risk factors and clinical manifestations of the children, and compared the high-risk factors, clinical manifestations and prognosis of BPD among different clinical subtypes by comparison…
- Trial name
- NCT04237844
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Wang Jianhui
Respiratory Syncytial Virus Infections
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease.
- Trial name
- NCT01155193
- Volunteers
- 30,804 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Bronchopulmonary Dysplasia
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube).
- Trial name
- NCT01440647
- Testing
- Extubation to NIPPV, Extubation to CPAP
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Infant, Newborn, Infant, Low Birth Weight
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Surfactant 1 (NCT01203358)
- Testing
- Exosurf, Survanta
- Where
- 13 sites in United States
- Volunteers
- 617 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress, Newborn, Ventilator Induced Lung Injury
Ventilatory Parameters and Inflammatory Responses of Neonates Ventilated by Different Modes of Ventilation
The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient…
- Trial name
- NCT01514331
- Testing
- SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee), PSV+VG (pressure support ventilation+volume guarantee)
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Gazi University
Surfactant Deficiency Syndrome Neonatal
deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants
Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like surfactant…
- Trial name
- deMISTify (NCT07522346)
- Testing
- Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy, Control (Minimally Invasive Surfactant Therapy)
- Where
- Australia
- Volunteers
- 36 people
- Sponsor
- Murdoch Childrens Research Institute
Respiratory Insufficiency Syndrome of Newborn, Infant, Premature, Diseases
PEEP and V/Q Mismatch in Premature Infants
Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange.
- Trial name
- NCT03109613
- Testing
- Positive end-expiratory pressure (PEEP)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Children's Hospital of Philadelphia
Bronchopulmonary Dysplasia, Respiratory Tract Infections
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Tract Infections, Premature Birth of Newborn
- Trial name
- NCT02023788
- Testing
- PNEUMOSTEM
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Medipost Co Ltd.
Bronchopulmonary Dysplasia, Extremely Premature Infants
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia
Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD).
- Conditions
- Bronchopulmonary Dysplasia, Extremely Premature Infants, Severe BPD That Conventional Therapies Has Failed, No Severe Congenital Anomalies
- Trial name
- NCT01207869
- Testing
- ucMSCs, Normal saline
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- China Medical University Hospital
Severe Bronchopulmonary Dysplasia
Aerosolized Albuterol Use in Severe BPD
Currently several dose schedules of Albuterol are administered via nebulization to infants in the neonatal and infant intensive care unit (N/IICU).
- Trial name
- NCT02766673
- Testing
- Albuterol Sulfate, Sterile Saline
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's Hospital of Philadelphia