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Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room

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: NCT04282369
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ilker Gönen, Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary:
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress

Condition or disease Intervention/treatment Phase
Respiratory Disease Respiratory Insufficiency Device: HHHFNC Device: NCPAP Device: NIPPV Device: NHFO Not Applicable

Detailed Description:
In this study, it is aimed to search the efficacy and comfort of the four different non-invasive ventilation modes in the delivery room. HHFNC, NCPAP, NIPPV and NHFO modes are used for the respiratory distress of the late preterm and term babies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 15, 2020

Arm Intervention/treatment
Active Comparator: HHFNC
In this group patients will receive respiratory support by high flow nasal cannula.
Device: HHHFNC
noninvasive ventilation modality

Active Comparator: nCPAP
In this group patients will receive respiratory support by nasal CPAP.
Device: NCPAP
noninvasive ventilation modality

Active Comparator: nIPPV
In this group patients will receive respiratory support by nasal IPPV.
Device: NIPPV
noninvasive ventilation modality

Active Comparator: nHFO
In this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation.
Device: NHFO
noninvasive ventilation modality




Primary Outcome Measures :
  1. Silverman Score [ Time Frame: 6 months ]
    The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.


Secondary Outcome Measures :
  1. N-PASS score [ Time Frame: 6 months ]
    evaluation of the comfort of the four different noninvasive ventilation modes



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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.


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Ages Eligible for Study:   up to 2 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • late preterm and term infants with respiratory distress

Exclusion Criteria:

  • intubation for the respiratory distres.
  • major abnormalities

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): NCT04282369


Contacts
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Contact: ilker gönen +905322054822 ilkergonen81@hotmail.com

Locations
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Turkey
Kanuni Sultan Suleyman Research and Training Hospital Completed
Istanbul, Turkey, 34065
Kanuni Sultan Suleyman Research and Training Hospital Recruiting
Istanbul, Turkey
Contact: ilker gönen    +905322054822    ilkergonen81@hotmail.com   
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
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Responsible Party: Ilker Gönen, Neonatologist, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04282369    
Other Study ID Numbers: 32342545
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ilker Gönen, Kanuni Sultan Suleyman Training and Research Hospital:
respiratory distress, newborn, noninvasive ventilation
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases