Other Clinical Trial - Crossover Comparison of Tidal Volume Delivery

Status Recruiting

Clinical Trial Summary

Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.

Clinical Trial Description

Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III). ;

Study Design

Related Conditions & MeSH terms

Respiratory Distress Syndrome in Premature Infant
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn

Clinical Trial Details

NCT number	NCT04326270
Study type	Interventional
Source	Arkansas Children's Hospital Research Institute
Contact	Ashley Lynch, M.D.
Phone	501-412-0988
Email	allynch@uams.edu
Status	Recruiting
Phase	N/A
Start date	March 7, 2019
Completion date	June 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04016246` - Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation.	Phase 3
Enrolling by invitation	`NCT04118400` - Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates
Completed	`NCT01941745` - Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome	Phase 2
Not yet recruiting	`NCT04019106` - Budesonide With Intratracheal Surfactants in Extremely Preterm Infants	Phase 1/Phase 2
Not yet recruiting	`NCT04862377` - Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.	Phase 3
Not yet recruiting	`NCT05791331` - REspiratory MEchanics for Delivering Individualised Exogenous Surfactant	N/A
Completed	`NCT04086095` - Feasibility Study - Neofact	N/A
Not yet recruiting	`NCT05609877` - The NONA-LISA Trial	N/A
Active, not recruiting	`NCT03969992` - A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact	Phase 2
Completed	`NCT03700606` - Physiological Changes With High-Flow Nasal Cannula	N/A
Recruiting	`NCT04359134` - Combined Lung Ultrasounds and Transthoracic Electrical Bioimpedance in Preterm Infants With Respiratory Distress.
Not yet recruiting	`NCT06229821` - Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants	N/A
Recruiting	`NCT05446389` - PAL to Improve Oral Feeding for Infants With Chronic Lung Disease	N/A
Withdrawn	`NCT04914715` - nHFOV Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome	N/A
Recruiting	`NCT03825835` - 30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants	N/A
Recruiting	`NCT03562182` - Effect of Steroid Administration on Maternal Blood Levels of hLPCAT1 mRNA
Completed	`NCT05031650` - Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room	N/A
Completed	`NCT03306524` - The Role of Circuit Flow During Mechanical Ventilation of Neonates	N/A
Completed	`NCT01473264` - Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)	Phase 1/Phase 2
Completed	`NCT03548324` - Enteral Nutrition Tolerance And REspiratory Support (ENTARES)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms