Respiratory InsufficiencyNCT02632799
Airway Pressure During Nasal High Flow and CPAP in Neonates
A study testing NHF small cannula, NHF big cannula and CPAP in people with Respiratory Insufficiency, run by Research Center of Maternal and Child Health Protection, Armenia at 2 sites in Armenia.
Trial summary
Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. The aim of the study was to investigate airway pressure during NHF and CPAP in neonates. Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- NHF small cannula, NHF big cannula and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesArmenia
- Study dates
- Jan 2015to Aug 2015
- 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 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term newborns
Who cannot join
- Newborns with any medical problems after birth
- Absent of parents consents
Trial locations and contacts
2 sites in 1 country.
Armenia2 sites
Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health
Yerevan, 0002
RCMCHP
Yerevan, 0002
About this study
Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. The aim of the study was to investigate airway pressure during NHF and CPAP in neonates.
Read the detailed description
Methods: A physiological study which measured pressure intra-nasally with micro (750 µm) pressure probes (Millar, USA) in 10 (5M / 5F) healthy newborns with mean gestation age 37.18 (SD 1.29) wk and mean birth weight of 2414 (SD 503.13) g. NHF was applied at 8 L/min (AIRVO 2) through smaller (OPT 314) and larger (OPT 316) Optiflow nasal cannula; CPAP 5 cmH20 was produced by a Bubble CPAP system and nasal mask interface at constant flow 8 L/min (Fisher \& Paykel Healthcare, NZ). Values are expressed in cmH20 as means and standard deviations (SD).
- Conditions
- Respiratory Insufficiency
- Being tested
- NHF small cannula, NHF big cannula, CPAP
- Keywords
- Nasal High Flow, CPAP, airway pressure, newborn
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHF small cannulaDevice
Also called Optiflow, HFNC
NHF 8 l/min by Airvo 2 by small cannula
NHF big cannulaDevice
Also called Optiflow, HFNC
NHF 8 l/min by Airvo 2 by large cannula
CPAPDevice
Nsal CPAP 5cm H2o by face mask
| Study group | Role | What they receive |
|---|---|---|
| NHF small cannula | Experimental | NHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow) Receives: Device: NHF small cannula |
| NHF big cannula | Experimental | NHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple) Receives: Device: NHF big cannula |
| Mask CPAP | Experimental | CPAP 5cm H2O Receives: Device: CPAP |
| no intervention | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper airway pressure generated by NHF compared to CPAP
Pressure in upper airways
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Center of Maternal and Child Health Protection, Armenia
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Pavel Mazmanyan, MD PhD, Principal investigator, Research Center of Maternal and Child Health Protection, Armenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632799
- Sponsor's protocol ID
- RCMCHP012
- Status last verified
- Oct 2019
- First submitted
- 10 Sep 2015
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Pressure During Nasal High Flow and CPAP in Neonates
- ClinicalTrials.gov ID
- NCT02632799
- Acronym / sponsor ID
- RCMCHP012
- Conditions
- Respiratory Insufficiency
- Keywords
- Nasal High Flow, CPAP, airway pressure, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Research Center of Maternal and Child Health Protection, ArmeniaUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Dec 2015 (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.
Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. The aim of the study was to investigate airway pressure during NHF and CPAP in neonates.
Detailed description
Methods: A physiological study which measured pressure intra-nasally with micro (750 µm) pressure probes (Millar, USA) in 10 (5M / 5F) healthy newborns with mean gestation age 37.18 (SD 1.29) wk and mean birth weight of 2414 (SD 503.13) g. NHF was applied at 8 L/min (AIRVO 2) through smaller (OPT 314) and larger (OPT 316) Optiflow nasal cannula; CPAP 5 cmH20 was produced by a Bubble CPAP system and nasal mask interface at constant flow 8 L/min (Fisher \& Paykel Healthcare, NZ). Values are expressed in cmH20 as means and standard deviations (SD).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NHF small cannula | Experimental | Device: NHF small cannulaNHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow) |
| NHF big cannula | Experimental | Device: NHF big cannulaNHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple) |
| Mask CPAP | Experimental | Device: CPAPCPAP 5cm H2O |
| no intervention | No intervention | –control |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy term newborns
Key exclusion criteria (2 listed)
- Newborns with any medical problems after birth
- Absent of parents consents
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 |
|---|---|---|
| NHF small cannulaAlso: Optiflow, HFNCNHF 8 l/min by Airvo 2 by small cannula | Device | NHF small cannula |
| NHF big cannulaAlso: Optiflow, HFNCNHF 8 l/min by Airvo 2 by large cannula | Device | NHF big cannula |
| CPAPNsal CPAP 5cm H2o by face mask | Device | Mask CPAP |
Primary outcome
Upper airway pressure generated by NHF compared to CPAP
Time frame: Up to 1 hour
Pressure in upper airways
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 31 Oct 2019.
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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.
Pavel Mazmanyan, MD PhD principal investigator
Research Center of Maternal and Child Health Protection, Armenia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NHF small cannula, NHF big cannula and CPAP in people with Respiratory Insufficiency, run by Research Center of Maternal and Child Health Protection, Armenia at 2 sites 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 1 inclusion and 2 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 31 Oct 2019. 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 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?
Upper airway pressure generated by NHF compared to CPAP (time frame: Up to 1 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 31 Oct 2019.