RDS - InfantsNCT04459429
Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns
A study testing Change of cannula size in people with RDS - Infants and TTN, run by Erebouni Medical Center at 1 site in Armenia.
Trial summary
Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory support in newborns. Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio because leak can influence the delivered pressure. Read more about this study
- Who is it for?
- Ages 1 hour to 2 days
- Conditions the study is for
- RDS - Infants, TTN
- What is being tested?
- Change of cannula size
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteArmenia
- Study dates
- 26 Jun 2020to 24 Dec 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 1 hour to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term and near term newborns with respiratory distress receiving treatment with NHF
- ≤ 48 hours old
- FiO2 ≥ 0,4
- Written parental informed consent
Who cannot join
- Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician (meet nHF failure criteria).
- Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
- A parent has not given written informed consent to their baby's participation.
- Prior intubation and/or surfactant administration
- Known or suspected hypoxic ischemic encephalopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cannula Size on Peripheral Oxygen Saturation During Nasal High Flow Therapy in Neonates With Respiratory Distress
Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory support in newborns.
Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio because leak can influence the delivered pressure.
To the best of our knowledge, this is the first study to investigate the effect of using different NHF cannula size on peripheral oxygen saturation in newborns with respiratory distress.
Read the detailed description
NHF will be applied at 8 L/min using the AIRVO 2 through smaller and larger Optiflow nasal cannula. The study will have a randomized crossover design. The larger or smaller cannula size will be applied as the first intervention during each experiment. During each experiment, if the larger cannula is applied first, then the smaller cannula will be applied second and if the smaller cannula is applied first, then the larger cannula will be applied second. Each experiment will last for 1.5 hour.
- During baseline, supplemental oxygen will be added during NHF therapy to keep SpO2 in normal ranges (90%-94%). When the SpO2 has stabilized then the level of supplemental oxygen will be set for the entire experiment unless there is a significant change in SpO2 as determined by the attending consultant.
- There will be three consecutive 30-min periods of recording during each experiment and each experiment will last approximately 1.5 hour.
- Ventilation will be assessed by Respiratory Inductance Plethysmography (Respitrace) and transcutaneous carbon dioxide and oxygen.
- Recordings will be made using ADInstruments Powerlab and Labchart software with video recording of the patient.
- Routine measurement of heart rate, respiratory rate and oxygen saturations will be performed as per standard neonatal practice.
The researcher is an experienced neonatal consultant who will be directly observing the baby throughout the study.
- Conditions
- RDS - Infants, TTN
- Being tested
- Change of cannula size
- Keywords
- RDS, TTN, Nasal High Flow Therapy, Newborn
- Medical subject headings
- RDS - infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of cannula sizeDevice
During nasal High Flow Therapy with fixed flow of 8 l/min, the cannula size will be changed from smaller-to-larger or larger-to-smaller
| Study group | Role | What they receive |
|---|---|---|
| NHF by smaller cannula | Experimental | Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula Receives: Device: Change of cannula size |
| NHF by larger cannula | Experimental | Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula Receives: Device: Change of cannula size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral oxygen saturation (SpO2 )
The difference in SpO2 between the period of using the larger cannula versus the smaller cannula
Measured: 1.5 hour
Secondary outcomes (6)
inspiratory effort
The difference in inspiratory effort between the period of using the larger cannula versus the smaller cannula
Measured: 1.5 hour
Respiratory rate
The change in respiratory rate between the period of using the larger cannula versus the smaller cannula
Measured: 1.5 hour
Relative minute ventilation
The difference in relative minute ventilation (inspiratory effort x respiratory rate) during the periods of using the larger cannula versus smaller cannula
Measured: 1.5 hour
Pulse rate
The difference in pulse rate between the period of using the larger cannula versus the smaller cannula
Measured: 1.5 hour
Transcutaneous carbon dioxide
The difference in TcCO2 between the period of using the larger cannula versus the smaller cannula
Measured: 1.5 hour
Transcutaneous oxygen
The difference in TcO2 between the period of using the larger cannula versus the smaller cannula
Measured: 1.5 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start26 Jun 2020
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RDS - InfantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erebouni Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Pavel Mazmanyan, Erebouni Medical Center
- Investigators
- Pavel Mazmanyan, MD, PhD, Principal investigator, Erebouni Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459429
- Sponsor's protocol ID
- Erebouni01Neonatal
- Status last verified
- Jun 2021
- First submitted
- 1 Jul 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no intent to share individual data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannula Size on Peripheral Oxygen Saturation During Nasal High Flow Therapy in Neonates With Respiratory Distress
- ClinicalTrials.gov ID
- NCT04459429
- Acronym / sponsor ID
- Erebouni01Neonatal
- Conditions
- RDS - Infants, TTN
- Keywords
- RDS, TTN, Nasal High Flow Therapy, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Erebouni Medical CenterUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 7 Jul 2020 (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.
Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory support in newborns.
Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio because leak can influence the delivered pressure.
To the best of our knowledge, this is the first study to investigate the effect of using different NHF cannula size on peripheral oxygen saturation in newborns with respiratory distress.
Detailed description
NHF will be applied at 8 L/min using the AIRVO 2 through smaller and larger Optiflow nasal cannula. The study will have a randomized crossover design. The larger or smaller cannula size will be applied as the first intervention during each experiment. During each experiment, if the larger cannula is applied first, then the smaller cannula will be applied second and if the smaller cannula is applied first, then the larger cannula will be applied second. Each experiment will last for 1.5 hour.
- During baseline, supplemental oxygen will be added during NHF therapy to keep SpO2 in normal ranges (90%-94%). When the SpO2 has stabilized then the level of supplemental oxygen will be set for the entire experiment unless there is a significant change in SpO2 as determined by the attending consultant.
- There will be three consecutive 30-min periods of recording during each experiment and each experiment will last approximately 1.5 hour.
- Ventilation will be assessed by Respiratory Inductance Plethysmography (Respitrace) and transcutaneous carbon dioxide and oxygen.
- Recordings will be made using ADInstruments Powerlab and Labchart software with video recording of the patient.
- Routine measurement of heart rate, respiratory rate and oxygen saturations will be performed as per standard neonatal practice.
The researcher is an experienced neonatal consultant who will be directly observing the baby throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover
| Arm | Type | Receives |
|---|---|---|
| NHF by smaller cannula | Experimental | Device: Change of cannula sizeNasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula |
| NHF by larger cannula | Experimental | Device: Change of cannula sizeNasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula |
Who may qualify
- Ages
- 1 hour to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Term and near term newborns with respiratory distress receiving treatment with NHF
- ≤ 48 hours old
- FiO2 ≥ 0,4
- Written parental informed consent
Key exclusion criteria (5 listed)
- Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician (meet nHF failure criteria).
- Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
- A parent has not given written informed consent to their baby's participation.
- Prior intubation and/or surfactant administration
- Known or suspected hypoxic ischemic encephalopathy
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 |
|---|---|---|
| Change of cannula sizeDuring nasal High Flow Therapy with fixed flow of 8 l/min, the cannula size will be changed from smaller-to-larger or larger-to-smaller | Device | NHF by larger cannula, NHF by smaller cannula |
Primary outcome
Peripheral oxygen saturation (SpO2 )
Time frame: 1.5 hour
The difference in SpO2 between the period of using the larger cannula versus the smaller cannula
6 secondary outcomes
inspiratory effort
Time frame: 1.5 hour
Respiratory rate
Time frame: 1.5 hour
Relative minute ventilation
Time frame: 1.5 hour
Pulse rate
Time frame: 1.5 hour
Transcutaneous carbon dioxide
Time frame: 1.5 hour
Transcutaneous oxygen
Time frame: 1.5 hour
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 30 Jun 2021.
- Individual participant dataSharing planned: No. There is currently no intent to share individual data with other researchers.
Related trials for RDS - Infants
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
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.
Pavel Mazmanyan, MD, PhD principal investigator
Erebouni Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change of cannula size in people with RDS - Infants and TTN, run by Erebouni Medical Center at 1 site in Armenia.
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 4 inclusion and 5 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 30 Jun 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 Armenia. 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?
Peripheral oxygen saturation (SpO2 ) (time frame: 1.5 hour). 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 30 Jun 2021.