Extreme PrematurityNCT03649282
HFNC and NCPAP in Extremely Preterm Infants
A study testing HFNC and NCPAP in people with Extreme Prematurity, run by Guilherme Sant'Anna, MD at 2 sites in Canada.
Trial summary
To avoid or decrease the rate of complications in preterm infants after disconnection from a mechanical ventilation (extubation), non-invasive respiratory support is routinely used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extreme Prematurity
- What is being tested?
- HFNC and NCPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2013to Apr 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants with birth weight ≤ 1250 grams
- Infants that have been mechanically ventilated and undergoing their first elective extubation attempt
Who cannot join
- Major congenital anomalies, neuromuscular disease, hemodynamic instability (use of vasopressors or hypotension).
- Infants reintubated before initiation or during data collection.
- Parental/legal guardian consent not obtained.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal Children's Hospital
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
About this study
Official title: Comparisons of the Dynamic of the Cardiorespiratory System Behavior of Extreme Preterm Infants Receiving Nasal CPAP or High Flow Nasal Cannula During the Immediate Post-extubation Period
To avoid or decrease the rate of complications in preterm infants after disconnection from a mechanical ventilation (extubation), non-invasive respiratory support is routinely used. While infants are most commonly extubated to nasal continuous positive airway pressure (NCPAP), high flow nasal cannula (HFNC) has emerged as an attractive alternative. However, research regarding the safety and efficacy of HFNC in the most extreme preterm infants is limited. Therefore, we hypothesize that immediately after extubation, measures of heart rate and respiratory behavior may be useful to investigate for any differences between HFNC and NCPAP.
Read the detailed description
Infants will be studied 30 min after extubation on both modes of support, provided in a random order. A transition period of 15 min between modes will be given. For each mode, recordings will be performed for 40 minutes. Analysis of these recordings will be done off line.
- Conditions
- Extreme Prematurity
- Being tested
- HFNC, NCPAP
- Keywords
- NCPAP, HFNC, Preterm infants, Cardiorespiratory behaviour, Non-invasive respiratory support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCOther
HFNC therapy will be delivered with a system that provides heated, humidified high flow of gas through a tube that maintains the temperature and humidification. This intervention will involve the delivery of gas (air/oxygen) at a high flow rate, using an adequate nasal cannulae size and a cannula/nostril diameter ratio between 0.5-0.8.
NCPAPOther
NCPAP will be provided as either bubble CPAP or through a ventilator, and will deliver a regulated pressure of gas (air/oxygen) to the patient through infant binasal prongs as interface. Nasal prong sizes will be chosen according to manufacturer recommendations.
| Study group | Role | What they receive |
|---|---|---|
| HFNC/NCPAP | Experimental | HFNC will be provided for 45 minutes followed by NCPAP for 45 minutes. Cardiorespiratory signals including electrocardiogram (ECG), respiratory inductive plethysmography (RIP), oxygen saturation (SpO2) and Pulse rate will be recorded continuously during the interventions and analyzed offline. Receives: Other: HFNC; Other: NCPAP |
| NCPAP/HFNC | Experimental | NCPAP will be provided for 45 minutes followed by HFNC for 45 minutes. Cardiorespiratory signals including electrocardiogram (ECG), respiratory inductive plethysmography (RIP), oxygen saturation (SpO2) and Pulse rate will be recorded continuously during the interventions and analyzed offline. Receives: Other: HFNC; Other: NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences on Heart Rate Variability in extremely preterm infants receiving HFNC and NCPAP
Cardiac signals from the electrocardiogram will be continuously measured throughout the recordings. Analysis of these signals will be performed offline to calculate heart rate variability using linear and nonlinear methods.
Measured: Immediate post-extubation period
Differences on Respiratory Variability in extremely preterm infants receiving HFNC and NCPAP
Respiratory variability will be calculated by using analysis of respiratory inductive pletysmography signals from the recordings during HFNC and NCPAP. Desaturation events will also be calculated from these recordings.
Measured: Immediate post-extubation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study startOct 2013
- Primary completionAug 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extreme PrematurityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guilherme Sant'Anna, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Guilherme M Sant'Anna, MD, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649282
- Sponsor's protocol ID
- 12-342-PED
- Status last verified
- Aug 2018
- First submitted
- 21 Aug 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of the Dynamic of the Cardiorespiratory System Behavior of Extreme Preterm Infants Receiving Nasal CPAP or High Flow Nasal Cannula During the Immediate Post-extubation Period
- ClinicalTrials.gov ID
- NCT03649282
- Acronym / sponsor ID
- 12-342-PED
- Conditions
- Extreme Prematurity
- Keywords
- NCPAP, HFNC, Preterm infants, Cardiorespiratory behaviour, Non-invasive respiratory support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Guilherme Sant'Anna, MDUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Aug 2018 (actual)
- 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.
To avoid or decrease the rate of complications in preterm infants after disconnection from a mechanical ventilation (extubation), non-invasive respiratory support is routinely used. While infants are most commonly extubated to nasal continuous positive airway pressure (NCPAP), high flow nasal cannula (HFNC) has emerged as an attractive alternative. However, research regarding the safety and efficacy of HFNC in the most extreme preterm infants is limited. Therefore, we hypothesize that immediately after extubation, measures of heart rate and respiratory behavior may be useful to investigate for any differences between HFNC and NCPAP.
Detailed description
Infants will be studied 30 min after extubation on both modes of support, provided in a random order. A transition period of 15 min between modes will be given. For each mode, recordings will be performed for 40 minutes. Analysis of these recordings will be done off line.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC/NCPAP | Experimental | Other: HFNC, Other: NCPAPHFNC will be provided for 45 minutes followed by NCPAP for 45 minutes. Cardiorespiratory signals including electrocardiogram (ECG), respiratory inductive plethysmography (RIP), oxygen saturation (SpO2) and Pulse rate will be recorded continuously during the interventions and analyzed offline. |
| NCPAP/HFNC | Experimental | Other: HFNC, Other: NCPAPNCPAP will be provided for 45 minutes followed by HFNC for 45 minutes. Cardiorespiratory signals including electrocardiogram (ECG), respiratory inductive plethysmography (RIP), oxygen saturation (SpO2) and Pulse rate will be recorded continuously during the interventions and analyzed offline. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Infants with birth weight ≤ 1250 grams
- Infants that have been mechanically ventilated and undergoing their first elective extubation attempt
Key exclusion criteria (3 listed)
- Major congenital anomalies, neuromuscular disease, hemodynamic instability (use of vasopressors or hypotension).
- Infants reintubated before initiation or during data collection.
- Parental/legal guardian consent not obtained.
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 |
|---|---|---|
| HFNCHFNC therapy will be delivered with a system that provides heated, humidified high flow of gas through a tube that maintains the temperature and humidification. This intervention will involve the delivery of gas (air/oxygen) at a high flow rate, using an adequate nasal cannulae size and a cannula/nostril diameter ratio between 0.5-0.8. | Other | HFNC/NCPAP, NCPAP/HFNC |
| NCPAPNCPAP will be provided as either bubble CPAP or through a ventilator, and will deliver a regulated pressure of gas (air/oxygen) to the patient through infant binasal prongs as interface. Nasal prong sizes will be chosen according to manufacturer recommendations. | Other | HFNC/NCPAP, NCPAP/HFNC |
Primary outcome
Differences on Heart Rate Variability in extremely preterm infants receiving HFNC and NCPAP
Time frame: Immediate post-extubation period
Cardiac signals from the electrocardiogram will be continuously measured throughout the recordings. Analysis of these signals will be performed offline to calculate heart rate variability using linear and nonlinear methods.
Differences on Respiratory Variability in extremely preterm infants receiving HFNC and NCPAP
Time frame: Immediate post-extubation period
Respiratory variability will be calculated by using analysis of respiratory inductive pletysmography signals from the recordings during HFNC and NCPAP. Desaturation events will also be calculated from these recordings.
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 28 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Extreme Prematurity
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Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
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Effects of Transitional Circulation in ELBW Infants
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Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
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IVH- Intraventricular Hemorrhage, Extreme Prematurity
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.
Guilherme M Sant'Anna, MD, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and NCPAP in people with Extreme Prematurity, run by Guilherme Sant'Anna, MD at 2 sites 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 3 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 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Differences on Heart Rate Variability in extremely preterm infants receiving HFNC and NCPAP (time frame: Immediate post-extubation period). The study lists 2 primary outcomes in all. 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 28 Aug 2018.