search
Back to results

Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive Ventilation

Primary Purpose

Respiratory Distress Syndrome, Newborn, Chronic Lung Disease of Newborn (Diagnosis)

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Drager VN500 Ventilator
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring diaphragm, non-invasive ventilation, high-frequency oscillation, CPAP

Eligibility Criteria

48 Hours - 90 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically stable preterm infants with birth weights ≤1500g admitted to the neonatal intensive care unit (NICU) at the Children's and Women's Hospital of BC
  • 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 21-40% 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), neonatal seizure.
  • infants with significant congenital heart disease (including symptomatic PDA).
  • infants with congenital anomalies of the diaphragm.
  • infants 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.
  • infants on nasal CPAP and requiring more than 40% oxygen
  • infants with significant gastric residuals and vomiting.
  • infants with facial anomalies.
  • infants with pneumothorax or pneumomediastinum.
  • infants in the immediate postoperative period.

Sites / Locations

  • British Columbia Women's Hospital and Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CPAP

NHFOV

Arm Description

Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants. Intervention: Device: Drager VN500 Ventilator

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 has not been well studied to date. Intervention: Device: Drager VN500 Ventilator

Outcomes

Primary Outcome Measures

The difference in the peak electrical activity of the diaphragm between CPAP and NHFOV.
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).

Secondary Outcome Measures

Difference in neural respiratory rate.
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
Difference in neural inspiratory time.
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
Difference in diaphragm energy expenditure.
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
Difference in transcutaneous pCO2 on the different modes of non-invasive ventilation.
TpCO2 bedside measurement.
Difference in the number of apnea episodes.
Clinical monitoring and vitals monitoring at the bedside.
Differences in SpO2 histogram classification between modes of ventilation.
Electronic vitals monitoring.

Full Information

First Posted
January 29, 2018
Last Updated
April 15, 2019
Sponsor
University of British Columbia
Collaborators
Sunnybrook Health Sciences Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT03422549
Brief Title
Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive Ventilation
Official Title
Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive High Frequency Oscillatory Ventilation (DEAP-NHFO Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

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 (CPAP) is one of the most commonly used tools but does not always provide enough support. A new option is non-invasive high frequency ventilation (NHFOV), 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 CPAP or NHFOV, 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 NHFOV 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 (CPAP) versus Non-Invasive High Frequency Ventilation (NHFOV) on respiratory pattern as assessed by the electrical activity of the diaphragm (EAdi) in very low birth weight (VLBW) preterm infants. The investigators hypothesize that in VLBW preterm infants with relative pulmonary insufficiency, NHFOV 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 NHFOV compared to CPAP. Clinicians are seeking alternative methods for providing non-invasive respiratory support to preterm infants. NHFOV is a relatively new modality that is being increasingly utilized in clinical practice but has not been well studied. This study will help the investigators determine how non-invasive high frequency ventilation 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 NHFOV 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, Chronic Lung Disease of Newborn (Diagnosis)
Keywords
diaphragm, non-invasive ventilation, high-frequency oscillation, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants. Intervention: Device: Drager VN500 Ventilator
Arm Title
NHFOV
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 has not been well studied to date. Intervention: Device: Drager VN500 Ventilator
Intervention Type
Device
Intervention Name(s)
Drager VN500 Ventilator
Intervention Description
This ventilator is capable of providing both CPAP and NHFOV support.
Primary Outcome Measure Information:
Title
The difference in the peak electrical activity of the diaphragm between CPAP and NHFOV.
Description
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
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 (CPAP and NHFOV).
Time Frame
4 hours
Title
Difference in neural inspiratory time.
Description
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
Time Frame
4 hours
Title
Difference in diaphragm energy expenditure.
Description
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
Time Frame
4 hours
Title
Difference in transcutaneous pCO2 on the different modes of non-invasive ventilation.
Description
TpCO2 bedside measurement.
Time Frame
4 hours
Title
Difference in the number of apnea episodes.
Description
Clinical monitoring and vitals monitoring at the bedside.
Time Frame
4 hours
Title
Differences in SpO2 histogram classification between modes of ventilation.
Description
Electronic vitals monitoring.
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Hours
Maximum Age & Unit of Time
90 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 the Children's and Women's Hospital of BC 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 21-40% 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), neonatal seizure. infants with significant congenital heart disease (including symptomatic PDA). infants with congenital anomalies of the diaphragm. infants 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. infants on nasal CPAP and requiring more than 40% oxygen infants with significant gastric residuals and vomiting. infants with facial anomalies. infants with pneumothorax or pneumomediastinum. infants in the immediate postoperative period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Wong, MD
Phone
604-875-2345
Ext
7348
Email
jonathan.wong@cw.bc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Claydon
Phone
604-875-2345
Ext
7408
Email
jclaydon@cw.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Wong, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Women's Hospital and Health Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Wong, MD
Phone
16048752345
Ext
7344
Email
jonathan.wong@cw.bc.ca
Email
jonathan.wong@cw.bc.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive Ventilation

We'll reach out to this number within 24 hrs