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Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive Ventilation

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ClinicalTrials.gov Identifier: NCT03422549
Recruitment Status : Not yet recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Jonathan Wong, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Chronic Lung Disease of Newborn (Diagnosis) Device: Drager VN500 Ventilator Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive High Frequency Oscillatory Ventilation (DEAP-NHFO Study)
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 1, 2019


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.




Primary Outcome Measures :
  1. The difference in the peak electrical activity of the diaphragm between CPAP and NHFOV. [ Time Frame: 4 hours ]
    Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).


Secondary Outcome Measures :
  1. Difference in neural respiratory rate. [ Time Frame: 4 hours ]
    Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).

  2. Difference in neural inspiratory time. [ Time Frame: 4 hours ]
    Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).

  3. Difference in diaphragm energy expenditure. [ Time Frame: 4 hours ]
    Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).

  4. Difference in transcutaneous pCO2 on the different modes of non-invasive ventilation. [ Time Frame: 4 hours ]
    TpCO2 bedside measurement.

  5. Difference in the number of apnea episodes. [ Time Frame: 4 hours ]
    Clinical monitoring and vitals monitoring at the bedside.

  6. Differences in SpO2 histogram classification between modes of ventilation. [ Time Frame: 4 hours ]
    Electronic vitals monitoring.



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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422549


Contacts
Contact: Jonathan Wong, MD 604-875-2345 ext 7348 jonathan.wong@cw.bc.ca
Contact: Jennifer Claydon 604-875-2345 ext 7408 jclaydon@cw.bc.ca

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

Responsible Party: Jonathan Wong, Neonatologist, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03422549     History of Changes
Other Study ID Numbers: H17-02003
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonathan Wong, University of British Columbia:
diaphragm
non-invasive ventilation
high-frequency oscillation
CPAP

Additional relevant MeSH terms:
Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases