Clinical trials: Work of Breathing
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
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
Respiratory Distress Syndrome
Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome
BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical…
- Trial name
- SLIS (NCT01440868)
- Testing
- Sustained lung inflation
- Where
- Italy
- Volunteers
- 276 people
- Sponsor
- University of Florence
Apnea of Prematurity, Apneic Spells of Newborn Nos
Cardio-respiratory Events in Preterm Infants During Transition
Cardio-respiratory events (CRE), defined as intermittent episodes of hypoxemia and/or bradycardia, are particularly common among preterm infants.
- Conditions
- Apnea of Prematurity, Apneic Spells of Newborn Nos, Patent Ductus Arteriosus, Premature Birth
- Trial name
- NCT04123691
- Testing
- pulse oximetry monitoring
- Where
- Italy
- Volunteers
- 32 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Infant,Premature
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2
To determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved stability of oxygenation.
- Trial name
- NCT03333161
- Testing
- Cardiorespiratory monitoring
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
Preterm Infant, RDS
Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants
In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range.
- Trial name
- FiO2-Contr (NCT01942473)
- Testing
- Automated FiO2 Control
- Where
- Germany
- Volunteers
- 17 people
- Sponsor
- University of Ulm
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Premature
Automated Oxygen Control in Preterms on Non-invasive Ventilation
This randomised controlled trial aims to investigate the effectiveness of closed-loop automated oxygen control (CLAC) in preterm infants receiving non-invasive respiratory support and determine if it reduces the duration of…
- Conditions
- Infant, Premature, Airway Morbidity
- Trial name
- NCT07622563
- Testing
- Closed loop automated oxygen control
- Where
- United Kingdom
- Volunteers
- 76 people
- Sponsor
- King's College Hospital NHS Trust
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 Insufficiency of Prematurity
Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)
The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD).
- Trial name
- NIPPV (NCT00433212)
- Testing
- nCPAP, NIPPV
- Where
- 35 sites in United States, Austria and 8 more
- Volunteers
- 1,011 people
- Sponsor
- McMaster University
Premature Infants, Apnea
Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants
Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects.
- Trial name
- NCT00389909
- Testing
- Doxapram
- Where
- 2 sites in France
- Volunteers
- 85 people
- Sponsor
- Jean Michel Hascoet
Prematurity, BPD - Bronchopulmonary Dysplasia
Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room
Despite significant improvement in preterm infant survival, the incidence of bronchopulmonary dysplasia (BPD) in infants born < 28 weeks gestational age (GA) has been relatively stable at ~40%, with 10,000-15,000 new cases…
- Conditions
- Prematurity, BPD - Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Newborn
- Trial name
- NCT03938532
- Testing
- Volume Targeted Ventilation (VTV) using the Philips Respironics NM3 monitor, Tidal Volume Measurement using the Philips Respironics NM3 monitor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Baystate Medical Center
Prematurity, Respiratory Distress Syndrome
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a…
- Conditions
- Prematurity, Respiratory Distress Syndrome, Apnea of Prematurity
- Trial name
- NICA (NCT03670732)
- Testing
- continuous positive airway pressure, nasal intermittent positive pressure ventilation
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Hyaline Membrane Disease
MISurf Versus InSurE. A Comparison of Minimally Invasive Surfactant Application Techniques in Preterm Infants
The lungs of infants born too early are extremely underdeveloped. Respiratory Distress Syndrome (RDS) is a condition that frequently develops in infants born more than 10 weeks early and leads to the collapse of their lungs.
- Trial name
- MIsurf (NCT01615016)
- Testing
- Minimally invasive endotracheal surfactant application
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- Hamilton Health Sciences Corporation
Preterm Birth, Premature Lungs
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to…
- Conditions
- Preterm Birth, Premature Lungs, Respiratory Distress Syndrome in Premature Infant
- Trial name
- NCT06295484
- Testing
- Alternating traditional CPAP, NIPPV, and high CPAP
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Sunnybrook Health Sciences Centre
Preterm Birth, Extreme Prematurity
Sustained Aeration of Infant Lungs Trial
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants.
- Trial name
- SAIL (NCT02139800)
- Testing
- Sustained Inflation, Standard of Care
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 460 people
- Sponsor
- University of Pennsylvania
Retinopathy of Prematurity
Inhaled Nitrous Oxide for Pain Relief During Eye Exam in the Pre-term Infant
The primary objective of the proposed study is to show that inhaled equimolar mixture of oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm infant, as compared to the current standard…
- Trial name
- NCT00623220
- Testing
- N2O, oxygen
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Nabeel Ali
Retinopathy of Prematurity, Pain
The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination
Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contributes to post-examination…
- Conditions
- Retinopathy of Prematurity, Pain, Premature Infant, Retinal Disease
- Trial name
- MASK-ROP (NCT03824782)
- Testing
- Phototherapy Mask
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- Sunnybrook Health Sciences Centre
Neonatal Respiratory Distress Syndrome, Prematurity
Breathing Variability and NAVA in Neonates
The current study is a crossover trial, aiming at evaluating the effect of NAVA -NIV compared to Nasal Intermittent Positive Pressure Ventilation (PC-NIV) at the same level of peak inspiratory pressure, in terms of…
- Trial name
- BRAVe NANO (NCT04000568)
- Testing
- Respiratory support: NAVA -NIV and PC-NIV
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico