Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive Ventilation

Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive High Frequency Oscillatory Ventilation (DEAP-NHFO Study)

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome, Newborn; Chronic Lung Disease of Newborn (Diagnosis)
• Intervention / Treatment: Device: Drager VN500 Ventilator

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Recruiting
      • British Columbia Women's Hospital and Health Centre
      • Contact: Jonathan Wong, MD; Phone Number: 7344 16048752345; Email: jonathan.wong@cw.bc.ca
      • Contact: Email: jonathan.wong@cw.bc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CPAP; Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants. Intervention: Device: Drager VN500 Ventilator	Device: Drager VN500 Ventilator; This ventilator is capable of providing both CPAP and NHFOV support.
Active Comparator: NHFOV; 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	Device: Drager VN500 Ventilator; This ventilator is capable of providing both CPAP and NHFOV support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in neural respiratory rate.	Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).	4 hours
Difference in neural inspiratory time.	Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).	4 hours
Difference in diaphragm energy expenditure.	Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).	4 hours
Difference in transcutaneous pCO2 on the different modes of non-invasive ventilation.	TpCO2 bedside measurement.	4 hours
Difference in the number of apnea episodes.	Clinical monitoring and vitals monitoring at the bedside.	4 hours
Differences in SpO2 histogram classification between modes of ventilation.	Electronic vitals monitoring.	4 hours

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Jonathan Wong, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: CPAP; non-invasive ventilation; diaphragm; high-frequency oscillation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Infant, Newborn, Diseases; Infant, Premature, Diseases; Lung Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: H17-02003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No