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Trial record 39 of 211 for:    Recruiting, Not yet recruiting, Available Studies | "Infant, Premature, Diseases"

Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV

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ClinicalTrials.gov Identifier: NCT02267018
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Michael Dunn, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn 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 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


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




Primary Outcome Measures :
  1. 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).


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 (nCPAP and NIHFV).

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

  3. 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. Difference in transcutaneous pCO2. [ Time Frame: 4 hours ]
  5. Number of apnea episodes. [ Time Frame: 4 hours ]


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Ages Eligible for Study:   up to 60 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 Sunnybrook Health Sciences Centre.
  • 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.

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): NCT02267018


Contacts
Contact: Michael Dunn, MD (416) 480-6100 ext 87777 michael.dunn@sunnybrook.ca
Contact: Jonathan Wong, MD (416) 480-6055 jonathanc.wong@mail.utoronto.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Michael S Dunn, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Michael Dunn, MD Sunnybrook Health Sciences Centre

Responsible Party: Dr. Michael Dunn, Staff Neonatologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02267018     History of Changes
Other Study ID Numbers: 001-2014
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Dr. Michael Dunn, Sunnybrook Health Sciences Centre:
nCPAP
High-Frequency Oscillator Ventilation
Diaphragm Electrical Activity

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