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Respiratory Distress Syndrome, NewbornNCT03366714

RAM Cannula Versus Short Bi-nasal Cannula in Respiratory Distress Syndrome

A study testing nasal CPAP support with RAM cannula and nasal CPAP support with Hudson cannula in people with Respiratory Distress Syndrome, Newborn, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Noninvasive ventilation defines methods of providing ventilation support with constant or variable pressure using nasal or nasopharyngeal interfaces without endotracheal intubation or tracheostomy. Read more about this study

Who is it for?
Ages 1 minute to 15 minutes
Conditions the study is for
Respiratory Distress Syndrome, Newborn
What is being tested?
nasal CPAP support with RAM cannula and nasal CPAP support with Hudson cannula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2017to 15 Aug 2018
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 minute to 15 minutes
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • gestational age between 26-34 weeks and,
  • born in our hospital and,
  • Patients with clinical findings (tachypnea, groaning, chest retractions) of RDS

Who cannot join

  • Patients who needed intubation to stabilize in the delivery room or who had severe congenital anomalies.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Turgut Özal Medical Center

    Malatya, 44280

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Efficacy of Noninvasive Ventilation With RAM Cannula Versus Short Bi-nasal Cannula in Respiratory Distress Syndrome of Preterm Infants

Noninvasive ventilation defines methods of providing ventilation support with constant or variable pressure using nasal or nasopharyngeal interfaces without endotracheal intubation or tracheostomy. Today, short binasal prongs and different types of nasal masks are the most commonly used nasal interfaces in the NICU with the aim of providing NIV.

RAM cannula (Neotech ™, Valencia, CA), a new nasal interface, is increasingly used in NID applications in newborn infants. The RAM cannula is available in the inspiration and expiration arms of the stroke while reducing the dead space in the respiratory tract due to the low nasal prong diameter. There are not enough studies comparing the effectiveness of the RAM cannula with other short binasal prongs or nasal masks.

Investigators compared the effectiveness and nasal injury rates of RAM cannula and short binasal prong as NIV interfaces in preterm infants.

Read the detailed description

In the past years endotracheal intubation and mechanical ventilation with surfactant therapy was the standard treatment of moderate to severe respiratory distress syndrome (RDS). Especially in the last 10 years, prolonged intubation and positive pressure ventilation have been shown to increase the frequency of bronchopulmonary dysplasia, a kind of chronic pulmonary disease. Intubation and positive pressure ventilation cause volu-trauma, baro-trauma, and alveolar secondary to bio-trauma, leading to excessive distension and inflammation, disrupting alveolar formation, resulting in fibrosis and bronchopulmonary dysplasia. Intubation and mechanical ventilation also involve ventilator-associated pneumonia. For this reason, strategies for lung protective ventilation have become increasingly widespread in recent years and noninvasive ventilation (NNV) applications without endotracheal intubation have become the first choice in neonatal ventilation.

Noninvasive ventilation defines methods of providing ventilation support with constant or variable pressure using nasal or nasopharyngeal interfaces without endotracheal intubation or tracheostomy. Noninvasive ventilation can be performed in a variety of forms such as continuous positive airway pressure (NCPAP) nasal intermittent positive-pressure ventilation (NIPPV) and high-flow nasal cannulae.

Different nasal interfaces are used to provide noninvasive ventilation support. For this purpose, there is no standard apparatus used in neonatal intensive care units (NICU). Nasopharyngeal cannulae are not currently recommended for use with NIV because they cause extensive resistance during spontaneous breathing, nasopharyngeal area damage and colonization, although they have been widely used in previous years. Today, short binasal prongs and different types of nasal masks are the most commonly used nasal interfaces in the NICU with the aim of providing NIV. Nasal interfaces are recommended to be placed on the surface without causing pressure loss. For this purpose, hoods and fixing apparatus are frequently used. For this reason, babies often become restless and agitated during NIV applications. In addition, necrosis and deformities may develop in septum due to pressure of nasal septum.

RAM cannula (Neotech ™, Valencia, CA), a new nasal interface, is increasingly used in NID applications in newborn infants. RAM seems ideal to allow effective and cranium development in the prevention of pressure damage to the face due to the design of the cannula and the need for head or face access to detect it. The RAM cannula is available in the inspiration and expiration arms of the stroke while reducing the dead space in the respiratory tract due to the low nasal prong diameter. Although the use of RAM cannula as a NIV interface in newborn intensive care units is becoming increasingly widespread, the number of studies related to RAM cannula is limited. Most of the studies investigating the effectiveness of this interface were made on artificial lung models. In the study of "Mukerji" and colleagues, the short binasal prong and RAM cannula were compared as interfaces in NIPPV application in the artificial lung model and it was found that carbon dioxide excretion in short binasal prongs was better than RAM cannula with an increase in peak inspiratory pressure. Studies conducted by Iyer and colleagues in the artificial lung model show that RAM leakage rates below 30% lead to adequate pressure transfer to the cannulae, while leakage rates above 50% reduce pressure transfer to the lungs. Similar results have also been found in the work of "Gerdes" et al. A number of studies have been conducted on the clinical use of RAM as a noninvasive ventilation interface and in these studies it has been shown that the use of RAM cannula as an interface in NCPAP, NIPPV or even nasal high frequency ventilation applications to provide NIV is not well tolerated and does not cause gastric perforation or nasal septum damage. In the study of "Nzegwu" et al. It has been shown that in two-thirds of the patients who were treated with RAM cannula and NIV support, the respiratory support was successfully cut off. Nevertheless, none of these studies compared the RAM cannula activity with the other binasal prongs or nasal masks. Investigators compared the effectiveness (rates of surfactant therapy application, rates of intubation, total NIV duration) and nasal injury rates of RAM cannula and short binasal prong as NIV interfaces in preterm infants at neonatal intensive care unit.

Considering the studies made in the artificial lung models of RAM cannulas, which are becoming increasingly widespread in the NICUs, because of their simple and simple design and easy connection to the standard circuits of the ventilators without any intervention, investigators think that the effectiveness of NIV application is insufficient compared to the short binasal cannula.

Being tested
nasal CPAP support with RAM cannula, nasal CPAP support with Hudson cannula
Keywords
Noninvasive ventilation, respiratory distress syndrome
Medical subject headings
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nasal CPAP support with RAM cannulaDevice

    Patients with respiratory distress syndrome who do not need intubation in the delivery room. This groub will be provided with non-invasive respiratory support RAM cannula.

  • nasal CPAP support with Hudson cannulaDevice

    Patients with respiratory distress syndrome who do not need intubation in the delivery room. This groub will be provided with non-invasive respiratory support Hudson cannula.

Study groups in NCT03366714
Study groupRoleWhat they receive
RAM cannulaExperimentalnasal CPAP support with RAM cannula
Receives: Device: nasal CPAP support with RAM cannula
Hudson cannula (short binasal cannula)Active comparatornasal CPAP support with Hudson cannula
Receives: Device: nasal CPAP support with Hudson cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nasal IPPV failure

    Non invasive ventilation failure in patients who underwent nasal IPPV with RAM cannula

    Measured: up to four weeks

Secondary outcomes (1)
  1. NİV duration

    In patients with NİV (nasal IPPV) who underwent RAM cannula or short binasal cannula (prong). We compared the time of NIV

    Measured: up to two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2017
  2. Study start1 Apr 2017
  3. Primary completion1 Jun 2018
  4. Study completion15 Aug 2018

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03366714
Sponsor's protocol ID
2017/40
Status last verified
Feb 2020
First submitted
24 Nov 2017
Last updated
19 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Davis P, Davies M, Faber B. A randomised controlled trial of two methods of delivering nasal continuous positive airway pressure after extubation to infants weighing less than 1000 g: binasal (Hudson) versus single nasal prongs. Arch Dis Child Fetal Neonatal Ed. 2001 Sep;85(2):F82-5. doi: 10.1136/fn.85.2.f82.

    PubMed 11517198
  • Gerdes JS, Sivieri EM, Abbasi S. Factors influencing delivered mean airway pressure during nasal CPAP with the RAM cannula. Pediatr Pulmonol. 2016 Jan;51(1):60-9. doi: 10.1002/ppul.23197. Epub 2015 Apr 7.

    PubMed 25851534
  • Nzegwu NI, Mack T, DellaVentura R, Dunphy L, Koval N, Levit O, Bhandari V. Systematic use of the RAM nasal cannula in the Yale-New Haven Children's Hospital Neonatal Intensive Care Unit: a quality improvement project. J Matern Fetal Neonatal Med. 2015 Apr;28(6):718-21. doi: 10.3109/14767058.2014.929659. Epub 2014 Jun 30.

    PubMed 24874561

Questions about this trial

What is this clinical trial studying?

A study testing nasal CPAP support with RAM cannula and nasal CPAP support with Hudson cannula in people with Respiratory Distress Syndrome, Newborn, run by Inonu University at 1 site in Turkey (Türkiye).

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 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 19 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 Turkey (Türkiye). 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?

Nasal IPPV failure (time frame: up to four weeks). 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 NCT03366714, which also lists 3 linked publications.

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 19 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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