Respiratory Distress Syndrome, NewbornNCT02267018
Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
A study testing Drager VN500 Ventilator in people with Respiratory Distress Syndrome, Newborn, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 60 days
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Drager VN500 Ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Drager VN500 Ventilator
- Keywords
- nCPAP, High-Frequency Oscillator Ventilation, Diaphragm Electrical Activity
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drager VN500 VentilatorDevice
This ventilator is capable of providing both nCPAP and NIHFV support.
| Study group | Role | What they receive |
|---|---|---|
| nCPAP | Active comparator | Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants. Receives: Device: Drager VN500 Ventilator |
| NIHFV | Active comparator | 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. Receives: Device: Drager VN500 Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 hours
Secondary outcomes (5)
Difference in neural respiratory rate.
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Measured: 4 hours
Difference in neural inspiratory time.
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Measured: 4 hours
Difference in diaphragm energy expenditure.
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).
Measured: 4 hours
Difference in transcutaneous pCO2.
As read from transcutaneous pCO2 monitor
Measured: 4 hours
Number of apnea episodes.
Pauses in electrical activity of the diaphragm of greater than 5 seconds and greater than 15 seconds
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startAug 2016
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Michael Dunn, Sunnybrook Health Sciences Centre
- Investigators
- Michael Dunn, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267018
- Sponsor's protocol ID
- 001-2014
- Status last verified
- Mar 2021
- First submitted
- 7 Oct 2014
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02267018
- Acronym / sponsor ID
- 001-2014
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- nCPAP, High-Frequency Oscillator Ventilation, Diaphragm Electrical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nCPAP | Active comparator | Device: Drager VN500 VentilatorNasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants. |
| NIHFV | Active comparator | Device: Drager VN500 VentilatorNon-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. |
Who may qualify
- Ages
- 2 to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drager VN500 VentilatorThis ventilator is capable of providing both nCPAP and NIHFV support. | Device | NIHFV, nCPAP |
Primary outcome
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).
5 secondary outcomes
Difference in neural respiratory rate.
Time frame: 4 hours
Difference in neural inspiratory time.
Time frame: 4 hours
Difference in diaphragm energy expenditure.
Time frame: 4 hours
Difference in transcutaneous pCO2.
Time frame: 4 hours
Number of apnea episodes.
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dunn, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drager VN500 Ventilator in people with Respiratory Distress Syndrome, Newborn, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the difference in the peak electrical activity of the diaphragm between nCPAP and NIHFV. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.