Respiratory Distress Syndrome, NewbornNCT02168257
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
A study testing RAM Cannula and Binasal Prong CPAP in people with Respiratory Distress Syndrome, Newborn and Continuous Positive Airway Pressure, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Continuous Positive Airway Pressure, Low Birth Weight Infants
- What is being tested?
- RAM Cannula and Binasal Prong CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Feb 2017
- 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
- Low Birth Weight Infant
- Currently on continuous positive aireway pressure of 5-7 cm water pressure
- Receiving continuous positive airway pressure support for > 24 hrs prior to enrollment
- Fraction of inspired oxygen requirement of 23-50%
Who cannot join
- Fraction of inspired oxygen > 50%
- Congenital defects of head, pulmonary or cardiovascular systems
- Chromosomal abnormalities/genetic syndromes
- Invasive Surgical Procedure within 24 hrs prior to enrollment
- Enrollment in separate clinical trial that has ongoing data collection
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102
About this study
The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.
- Conditions
- Respiratory Distress Syndrome, Newborn, Continuous Positive Airway Pressure, Low Birth Weight Infants
- Being tested
- RAM Cannula, Binasal Prong CPAP
- Keywords
- Nasal Cannula
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAM CannulaDevice
Binasal Prong CPAPDevice
| Study group | Role | What they receive |
|---|---|---|
| RAM Cannula CPAP | Experimental | CPAP provided by RAM Cannula Receives: Device: RAM Cannula |
| Binasal Prong CPAP | Active comparator | CPAP provided by binasal prong Receives: Device: Binasal Prong CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
Pulse oximetry
Measured: 3 hrs
Ventilation
transcutaneous carbon dioxide monitor
Measured: 3 hrs
Secondary outcomes (2)
Esophageal pressure measurements
Esophageal Pressure Catheter
Measured: 3 hrs
Apnea
3-channel pneumogram
Measured: 3 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil P Mulrooney, MD, Principal investigator, Children's Hospitals and Clinics of MinnesotaAndrea L Lampland, MD, Principal investigator, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168257
- Sponsor's protocol ID
- 1303-032
- Other IDs
- 47575
- Status last verified
- Jul 2017
- First submitted
- 18 Jun 2014
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
- ClinicalTrials.gov ID
- NCT02168257
- Acronym / sponsor ID
- 1303-032
- Conditions
- Respiratory Distress Syndrome, Newborn, Continuous Positive Airway Pressure, Low Birth Weight Infants
- Keywords
- Nasal Cannula
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 20 Jun 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.
The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAM Cannula CPAP | Experimental | Device: RAM CannulaCPAP provided by RAM Cannula |
| Binasal Prong CPAP | Active comparator | Device: Binasal Prong CPAPCPAP provided by binasal prong |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Low Birth Weight Infant
- Currently on continuous positive aireway pressure of 5-7 cm water pressure
- Receiving continuous positive airway pressure support for > 24 hrs prior to enrollment
- Fraction of inspired oxygen requirement of 23-50%
Key exclusion criteria (5 listed)
- Fraction of inspired oxygen > 50%
- Congenital defects of head, pulmonary or cardiovascular systems
- Chromosomal abnormalities/genetic syndromes
- Invasive Surgical Procedure within 24 hrs prior to enrollment
- Enrollment in separate clinical trial that has ongoing data collection
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 |
|---|---|---|
| RAM Cannula | Device | RAM Cannula CPAP |
| Binasal Prong CPAP | Device | Binasal Prong CPAP |
Primary outcome
Oxygenation
Time frame: 3 hrs
Pulse oximetry
Ventilation
Time frame: 3 hrs
transcutaneous carbon dioxide monitor
2 secondary outcomes
Esophageal pressure measurements
Time frame: 3 hrs
Apnea
Time frame: 3 hrs
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Neil P Mulrooney, MD principal investigator
Children's Hospitals and Clinics of Minnesota
Andrea L Lampland, MD principal investigator
Children's Hospitals and Clinics of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAM Cannula and Binasal Prong CPAP in people with Respiratory Distress Syndrome, Newborn and Continuous Positive Airway Pressure, run by Children's Hospitals and Clinics of Minnesota 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 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: stopped early, as of the sponsor's last update on 21 Jul 2017. 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 was stopped early (reason given: Lack of enrollment). 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?
Oxygenation (time frame: 3 hrs). 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 21 Jul 2017.