Back to resultsEvaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room
Primary Purpose
Respiratory Disease, Respiratory Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
HHHFNC
NCPAP
NIPPV
NHFO
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Disease focused on measuring respiratory distress, newborn, noninvasive ventilation
Eligibility Criteria
Inclusion Criteria:
- late preterm and term infants with respiratory distress
Exclusion Criteria:
- intubation for the respiratory distres.
- major abnormalities
Sites / Locations
- Kanuni Sultan Suleyman Research and Training Hospital
- Kanuni Sultan Suleyman Research and Training HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
HHFNC
nCPAP
nIPPV
nHFO
Arm Description
In this group patients will receive respiratory support by high flow nasal cannula.
In this group patients will receive respiratory support by nasal CPAP.
In this group patients will receive respiratory support by nasal IPPV.
In this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation.
Outcomes
Primary Outcome Measures
Silverman Score
The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.
Secondary Outcome Measures
N-PASS score
evaluation of the comfort of the four different noninvasive ventilation modes
Full Information
NCT ID
NCT04282369
First Posted
February 17, 2020
Last Updated
February 21, 2020
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04282369
Brief Title
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease, Respiratory Insufficiency
Keywords
respiratory distress, newborn, noninvasive ventilation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HHFNC
Arm Type
Active Comparator
Arm Description
In this group patients will receive respiratory support by high flow nasal cannula.
Arm Title
nCPAP
Arm Type
Active Comparator
Arm Description
In this group patients will receive respiratory support by nasal CPAP.
Arm Title
nIPPV
Arm Type
Active Comparator
Arm Description
In this group patients will receive respiratory support by nasal IPPV.
Arm Title
nHFO
Arm Type
Active Comparator
Arm Description
In this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation.
Intervention Type
Device
Intervention Name(s)
HHHFNC
Intervention Description
noninvasive ventilation modality
Intervention Type
Device
Intervention Name(s)
NCPAP
Intervention Description
noninvasive ventilation modality
Intervention Type
Device
Intervention Name(s)
NIPPV
Intervention Description
noninvasive ventilation modality
Intervention Type
Device
Intervention Name(s)
NHFO
Intervention Description
noninvasive ventilation modality
Primary Outcome Measure Information:
Title
Silverman Score
Description
The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
N-PASS score
Description
evaluation of the comfort of the four different noninvasive ventilation modes
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
late preterm and term infants with respiratory distress
Exclusion Criteria:
intubation for the respiratory distres.
major abnormalities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ilker gönen
Phone
+905322054822
Email
ilkergonen81@hotmail.com
Facility Information:
Facility Name
Kanuni Sultan Suleyman Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34065
Country
Turkey
Individual Site Status
Completed
Facility Name
Kanuni Sultan Suleyman Research and Training Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ilker gönen
Phone
+905322054822
Email
ilkergonen81@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room
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