Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 198 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03366714
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
İsmail Kürşad Gökce, Inonu University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Device: nasal CPAP support with RAM cannula Device: nasal CPAP support with Hudson cannula Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Efficacy of Noninvasive Ventilation With RAM Cannula Versus Short Bi-nasal Cannula in Respiratory Distress Syndrome of Preterm Infants
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : August 15, 2018


Arm Intervention/treatment
Experimental: RAM cannula
nasal CPAP support with RAM cannula
Device: nasal CPAP support with RAM cannula
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.

Active Comparator: Hudson cannula (short binasal cannula)
nasal CPAP support with Hudson cannula
Device: nasal CPAP support with Hudson cannula
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.




Primary Outcome Measures :
  1. Nasal IPPV failure [ Time Frame: up to four weeks ]
    Non invasive ventilation failure in patients who underwent nasal IPPV with RAM cannula


Secondary Outcome Measures :
  1. NİV duration [ Time Frame: up to two months ]
    In patients with NİV (nasal IPPV) who underwent RAM cannula or short binasal cannula (prong). We compared the time of NIV



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 15 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366714


Contacts
Layout table for location contacts
Contact: İsmail K Gökce, asst.prof +90 422 341 0660 ext 5374 ikgokce07@hotmail.com
Contact: Ramazan Özdemir, assoc.prof +90 422 341 0660 ext 5310 ramazanoz@yahoo.com.tr

Locations
Layout table for location information
Turkey
Turgut Özal Medical Center Recruiting
Malatya, Turkey, 44280
Contact: Hüseyin Kaya, MD    +90 422 341 0660 ext 5379    doctor_ctf@hotmail.com   
Sponsors and Collaborators
Inonu University

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: İsmail Kürşad Gökce, Departman of Pediatrics, Division of Neonatoloji, Inonu University
ClinicalTrials.gov Identifier: NCT03366714     History of Changes
Other Study ID Numbers: 2017/40
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by İsmail Kürşad Gökce, Inonu University:
Noninvasive ventilation, respiratory distress syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases