Acute Respiratory DeficiencyNCT02032511
Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)
An observational study of Acute Respiratory Deficiency and Prematurity, run by University of Michigan.
Trial summary
This study is designed to compare the effectiveness and ease of use of two commonly used NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Acute Respiratory Deficiency, Prematurity, Assisted Ventilation
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Apr 2014
- 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
- No healthy volunteers
- Child
Study population: infants less than or equal to 7kg with an order for nasal continuous positive pressure
Who may be able to join
- less than or equal to 7 kg
- order for nasal continuous positive pressure
Who cannot join
- patients greater than 7kg
- patients that do not have informed consent
About this study
Official title: Comparison of RAM Cannula NCPAP Versus Infant Flow NCPAP
This study is designed to compare the effectiveness and ease of use of two commonly used NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RAM Cannula Nasal Continuous Positive Airway Pressure | Not described | |
| Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who achieve unassisted breathing
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: No appreciable difference noted between methods of delivery
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory DeficiencyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Pape, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032511
- Sponsor's protocol ID
- HUM00073557
- Status last verified
- Jan 2017
- First submitted
- 7 Jan 2014
- Last updated
- 9 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of RAM Cannula NCPAP Versus Infant Flow NCPAP
- ClinicalTrials.gov ID
- NCT02032511
- Acronym / sponsor ID
- HUM00073557
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No appreciable difference noted between methods of delivery
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jan 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.
This study is designed to compare the effectiveness and ease of use of two commonly used NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAM Cannula Nasal Continuous Positive Airway Pressure | – | – |
| Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP) | – | – |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants less than or equal to 7kg with an order for nasal continuous positive pressure
Key inclusion criteria (2 listed)
- less than or equal to 7 kg
- order for nasal continuous positive pressure
Key exclusion criteria (2 listed)
- patients greater than 7kg
- patients that do not have informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who achieve unassisted breathing
Time frame: One year
Results and safety
The study was stopped early (reason given: No appreciable difference noted between methods of delivery). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Deficiency and Prematurity, run by University of Michigan.
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 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: stopped early, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: No appreciable difference noted between methods of delivery). Results are not available in the source record.
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?
Number of patients who achieve unassisted breathing (time frame: One year). 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 9 Jan 2017.