High Flow Nasal CannulaNCT03529994
Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)
An observational study of High Flow Nasal Cannula, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- High Flow Nasal Cannula
- What is being tested?
- Enrollment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2018to 1 Aug 2019
- Phase
- Observational
- 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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Convenience sample of infants on HFNC admitted to our NICU who meet inclusion criteria.
Who may be able to join
- Infants between 27 and 37 weeks corrected gestational age
- >4 days PNA
- Stable (i.e. not meeting exclusion criteria) and receiving non-invasive respiratory support (HFNC) for ≥ 12 hours
- Requiring ≤ 40% supplemental FiO2 as determined by the clinical care team for clinical care purposes independent of this study
Who cannot join
- Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of WOB measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Services, Inc.
Newark, Delaware, 19718
About this study
Official title: Work of Breathing and Oxygen Saturation Stability in Infants With Respiratory Insufficiency While Receiving Various Flow Rates of High Flow Nasal Cannula
The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.
- Conditions
- High Flow Nasal Cannula
- Being tested
- Enrollment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnrollmentOther
All infants enrolled will have work of breathing assessed.
| Study group | Role | What they receive |
|---|---|---|
| Enrollment | Not described Receives: Other: Enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work of breathing indices
Altering HFNC flow rates and its effect on work of breathing indices in preterm infants with respiratory insufficiency.
Measured: 2 hours
Secondary outcomes (1)
Intermittent hypoxia
Altering HFNC flow rates and its effect on intermittent hypoxia in preterm infants with respiratory insufficiency.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start15 Apr 2018
- Primary completion31 Jul 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Flow Nasal CannulaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children
- Responsible party
- Sponsor
- Investigators
- Kelley Kovatis, MD, Principal investigator, Christiana Care Health Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529994
- Sponsor's protocol ID
- DDD603875
- Status last verified
- May 2019
- First submitted
- 8 May 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work of Breathing and Oxygen Saturation Stability in Infants With Respiratory Insufficiency While Receiving Various Flow Rates of High Flow Nasal Cannula
- ClinicalTrials.gov ID
- NCT03529994
- Acronym / sponsor ID
- DDD603875
- Conditions
- High Flow Nasal Cannula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 21 May 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.
The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrollment | – | Other: Enrollment |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Convenience sample of infants on HFNC admitted to our NICU who meet inclusion criteria.
Key inclusion criteria (4 listed)
- Infants between 27 and 37 weeks corrected gestational age
- >4 days PNA
- Stable (i.e. not meeting exclusion criteria) and receiving non-invasive respiratory support (HFNC) for ≥ 12 hours
- Requiring ≤ 40% supplemental FiO2 as determined by the clinical care team for clinical care purposes independent of this study
Key exclusion criteria (1 listed)
- Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of WOB measurements
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 |
|---|---|---|
| EnrollmentAll infants enrolled will have work of breathing assessed. | Other | Enrollment |
Primary outcome
Work of breathing indices
Time frame: 2 hours
Altering HFNC flow rates and its effect on work of breathing indices in preterm infants with respiratory insufficiency.
1 secondary outcome
Intermittent hypoxia
Time frame: 2 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 28 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for High Flow Nasal Cannula
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Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Recruiting
Role of HFNC During FOB in Patients With Respiratory Failure
Respiratory Failure, Respiratory Failure With Hypercapnia
RecruitingObservational study
Brain-lung Interaction During Acute Respiratory Failure
Acute Respiratory Failure
Not yet recruiting
nCPAP Versus High-Flow Nasal Cannula in Preterm Infants With RDS
Respiratory Distress Syndrome, Premature Birth
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.
Kelley Kovatis, MD principal investigator
Christiana Care Health Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Flow Nasal Cannula, run by Christiana Care Health Services at 1 site in United States.
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 1 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 2019. 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 United States. 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?
Work of breathing indices (time frame: 2 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 28 Aug 2019.