Respiratory Distress Syndrome, NewbornRAMCANNCT03081611
RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants
A study testing Ram cannula and Short nasal prongs in people with Respiratory Distress Syndrome, Newborn and Noninvasive Ventilation, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation, Infant, Premature
- What is being tested?
- Ram cannula and Short nasal prongs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 30 Jan 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age 24-33.6
- Physician decision on the need for non invasive ventilation
- parental consent
Who cannot join
- Pneumothorax before recruitment
- Significant congenital heart disease or chromosomal disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial
Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants
Read the detailed description
Randomized control trial comparing Ram cannula to the regular, more investigated short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants with respiratory distress.
- Conditions
- Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation, Infant, Premature, Intubation, Intratracheal
- Being tested
- Ram cannula, Short nasal prongs
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ram cannulaDevice
Ventilatory support for preterm infants using Ram cannula
Short nasal prongsDevice
Ventilatory support for preterm infants using short nasal prongs
| Study group | Role | What they receive |
|---|---|---|
| Ram cannula | Experimental | NIPPV VIA Ram cannula Receives: Device: Ram cannula |
| Short nasal prongs | Active comparator | NIPPV VIA short nasal prongs Receives: Device: Short nasal prongs |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation
The need for intubation
Measured: 72 hours
Secondary outcomes (1)
nasal trauma
nasal trauma
Measured: during NIPPV procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 Jan 2018
- Primary completion30 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- Non Inferiority Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ori Hochwald , MD, Rambam Health Care Campus
- Investigators
- Ori Hochwald, MD, Principal investigator, NICU, Rambam Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081611
- Sponsor's protocol ID
- RAMCAN
- Acronym
- RAMCAN
- Status last verified
- Feb 2020
- First submitted
- 12 Mar 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hochwald O, Riskin A, Borenstein-Levin L, Shoris I, Dinur GP, Said W, Jubran H, Littner Y, Haddad J, Mor M, Timstut F, Bader D, Kugelman A. Cannula With Long and Narrow Tubing vs Short Binasal Prongs for Noninvasive Ventilation in Preterm Infants: Noninferiority Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):36-43. doi: 10.1001/jamapediatrics.2020.3579.
PubMed 33165539
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03081611
- Acronym / sponsor ID
- RAMCAN / RAMCAN
- Conditions
- Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation, Infant, Premature, Intubation, Intratracheal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 16 Mar 2017 (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.
Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants
Detailed description
Randomized control trial comparing Ram cannula to the regular, more investigated short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants with respiratory distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non Inferiority Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Ram cannula | Experimental | Device: Ram cannulaNIPPV VIA Ram cannula |
| Short nasal prongs | Active comparator | Device: Short nasal prongsNIPPV VIA short nasal prongs |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age 24-33.6
- Physician decision on the need for non invasive ventilation
- parental consent
Key exclusion criteria (2 listed)
- Pneumothorax before recruitment
- Significant congenital heart disease or chromosomal disorder
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 cannulaVentilatory support for preterm infants using Ram cannula | Device | Ram cannula |
| Short nasal prongsVentilatory support for preterm infants using short nasal prongs | Device | Short nasal prongs |
Primary outcome
intubation
Time frame: 72 hours
The need for intubation
1 secondary outcome
nasal trauma
Time frame: during NIPPV procedure
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 18 Feb 2020.
- Derived from this study: PubMed 33165539Hochwald O, Riskin A, Borenstein-Levin L, Shoris I, Dinur GP, Said W, Jubran H, Littner Y, Haddad J, Mor M, Timstut F, Bader D, Kugelman A. Cannula With Long and Narrow Tubing vs Short Binasal Prongs for Noninvasive Ventilation in Preterm Infants: Noninferiority Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):36-43. doi: 10.1001/jamapediatrics.2020.3579.
- Individual participant dataSharing planned: No
Related trials for Respiratory Distress Syndrome, Newborn
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
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
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.
Ori Hochwald, MD principal investigator
NICU, Rambam Medical Center, Haifa, Israel
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 Short nasal prongs in people with Respiratory Distress Syndrome, Newborn and Noninvasive Ventilation, run by Rambam Health Care Campus at 1 site in Israel.
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 3 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 18 Feb 2020. 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 Israel. 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?
intubation (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081611, which also lists 1 linked publication.
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 18 Feb 2020.