Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
NCT Number: NCT02267018
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but does not always provide enough support. A new option is non-invasive high frequency ventilation (NIHFV), which gently shakes the lungs to help with gas exchange and may decrease a baby's work of breathing. The investigators plan to study very low birth weight preterm babies who are generally well but require some support with their breathing. By inserting a special feeding tube with sensors into the stomach, the investigators can measure the electrical activity of the diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies receiving either nCPAP or NIHFV, the investigators will be able to measure and compare how each method of support affects a baby's breathing. This important study will help us determine the most appropriate breathing support for preterm babies.
Looking for future studies?
Notify Me2 day–60 day
All sexes
Interventional
Not applicable
Toronto, Ontario, M4N 3M5, Canada
Continuous Positive Airway Pressure is one of the most researched and accepted methods of delivering NIV to term and preterm infants. Non-invasive high frequency ventilation is a relatively new method of delivering NIV respiratory support in preterm infants. Preliminary studies suggest superiority over CPAP, and NIHFV is being increasingly utilized in clinical practice in an attempt to prevent intubation and minimize ventilation-induced lung injury in preterm infants. However, little is known about its mechanism of action and its effect on respiratory mechanics in the newborn. The objective of this study is to compare the effects of non-invasive ventilation (NIV) delivered by nasal Continuous Positive Airway Pressure (nCPAP) versus Non-Invasive High Frequency Ventilation (NIHFV) on respiratory pattern as assessed by the electrical activity of the diaphragm (EAdi) in very low birth weight (VLBW) preterm infants.
We hypothesize that in VLBW preterm infants with relative pulmonary insufficiency, NIHFV will reduce respiratory drive and improve ventilation, subsequently resulting in decreased patient diaphragm energy expenditure. This would be demonstrated by decreased neural respiratory rates and/or decreased peak electrical activity of the diaphragm while breathing on NIHFV compared to nCPAP.
Clinicians are seeking alternative methods for providing non-invasive respiratory support to preterm infants. NIHFV is a relatively new modality that is being increasingly utilized in clinical practice but has not been well studied. This study will help us determine how non-invasive high frequency ventilation (NIHFV) affects breathing in preterm infants, as compared to the more traditional modality of nasal CPAP. Therefore, clinicians will not only be able to better understand how NIHFV works, but also utilize this information to decide on the most appropriate respiratory support modality for preterm patients
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This ventilator is capable of providing both nCPAP and NIHFV support.
Time frame: 4 hours
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Time frame: 4 hours
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Time frame: 4 hours
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Time frame: 4 hours
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Time frame: 4 hours
As read from transcutaneous pCO2 monitor
Time frame: 4 hours
Pauses in electrical activity of the diaphragm of greater than 5 seconds and greater than 15 seconds
Sunnybrook Health Sciences Centre
Other
Effect of Nasal Continuous Positive Airway Pressure (nCPAP) Versus Non-Invasive High Frequency Ventilation (NIHFV) on the Diaphragm Electrical Activity in Very Low Birth Weight Preterm Infants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07693530
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Female Urogenital Diseases and Pregnancy Complications
Kayseri, Turkey (Türkiye)
View Trial DetailsNCT00814099
Acute Lung Injury, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Birmingham, Alabama, United States
View Trial DetailsNCT05065424
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Infant, Newborn, Diseases
Dallas, Texas, United States
View Trial DetailsNCT07422116
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Infant, Newborn, Diseases
Jakarta Pusat, DKI Jakarta, Indonesia
View Trial Details