- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02267018
Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinically stable preterm infants with birth weights ≤1500g admitted to the neonatal intensive care unit (NICU) at Sunnybrook Health Sciences Centre or BC Women's and Children's Hospital.
- Patient's on nasal continuous positive airway pressure of 6 to 8 cmH20 support for at least 48 hours, treated with methylxanthines for apnea of prematurity and requiring 25-40% of oxygen.
Exclusion Criteria:
- infants with congenital anomalies of the gastrointestinal tract, phrenic nerve damage, diaphragmatic paralysis, esophageal perforation;
- infants with congenital or acquired neurological deficit (including significant intraventricular hemorrhage >Grade II) [27], neonatal seizure;
- infants with significant congenital heart disease (including symptomatic PDA);
- infant with congenital anomalies of the diaphragm;
- infant with congenital anomalies of the respiratory tracts (e.g. Congenital Cystic Adenomatoid Malformation (CCAM)) infants requiring ongoing treatment for sepsis, necrotizing enterocolitis (NEC), antibiotics for lung infections, narcotic analgesics, or gastric motility agents will be excluded.
- infants on nasal CPAP and requiring more than 40% oxygen will be excluded from the study.
- infants with significant gastric residuals and vomiting, infants with facial anomalies, infants with pneumothorax or pneumomediastinum, and infants in the immediate postoperative period will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: nCPAP
Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants.
|
This ventilator is capable of providing both nCPAP and NIHFV support.
|
Active Comparator: NIHFV
Non-invasive high-frequency ventilation is a relatively new modality that is being utilized to support preterm infants and prevent the need for invasive ventilation, but this particular modality is has not been well studied to date.
|
This ventilator is capable of providing both nCPAP and NIHFV support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcome will be the difference in the peak electrical activity of the diaphragm between nCPAP and NIHFV.
Time Frame: 4 hours
|
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in neural respiratory rate.
Time Frame: 4 hours
|
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
|
4 hours
|
Difference in neural inspiratory time.
Time Frame: 4 hours
|
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
|
4 hours
|
Difference in diaphragm energy expenditure.
Time Frame: 4 hours
|
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
|
4 hours
|
Difference in transcutaneous pCO2.
Time Frame: 4 hours
|
As read from transcutaneous pCO2 monitor
|
4 hours
|
Number of apnea episodes.
Time Frame: 4 hours
|
Pauses in electrical activity of the diaphragm of greater than 5 seconds and greater than 15 seconds
|
4 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Dunn, MD, Sunnybrook Health Sciences Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001-2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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