Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
Primary Purpose
Respiratory Distress Syndrome, Newborn
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Drager VN500 Ventilator
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring nCPAP, High-Frequency Oscillator Ventilation, Diaphragm Electrical Activity
Eligibility Criteria
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.
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
nCPAP
NIHFV
Arm Description
Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants.
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.
Outcomes
Primary Outcome Measures
The primary outcome will be the difference in the peak electrical activity of the diaphragm between nCPAP and NIHFV.
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Secondary Outcome Measures
Difference in neural respiratory rate.
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Difference in neural inspiratory time.
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Difference in diaphragm energy expenditure.
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Difference in transcutaneous pCO2.
As read from transcutaneous pCO2 monitor
Number of apnea episodes.
Pauses in electrical activity of the diaphragm of greater than 5 seconds and greater than 15 seconds
Full Information
NCT ID
NCT02267018
First Posted
October 7, 2014
Last Updated
March 15, 2021
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT02267018
Brief Title
Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
Keywords
nCPAP, High-Frequency Oscillator Ventilation, Diaphragm Electrical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nCPAP
Arm Type
Active Comparator
Arm Description
Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants.
Arm Title
NIHFV
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Drager VN500 Ventilator
Intervention Description
This ventilator is capable of providing both nCPAP and NIHFV support.
Primary Outcome Measure Information:
Title
The primary outcome will be the difference in the peak electrical activity of the diaphragm between nCPAP and NIHFV.
Description
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Difference in neural respiratory rate.
Description
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Time Frame
4 hours
Title
Difference in neural inspiratory time.
Description
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Time Frame
4 hours
Title
Difference in diaphragm energy expenditure.
Description
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Time Frame
4 hours
Title
Difference in transcutaneous pCO2.
Description
As read from transcutaneous pCO2 monitor
Time Frame
4 hours
Title
Number of apnea episodes.
Description
Pauses in electrical activity of the diaphragm of greater than 5 seconds and greater than 15 seconds
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
60 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dunn, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
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