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NCT04282369 Clinical Trial

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

Respiratory Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04282369
Other study ID # 32342545
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 18, 2020
Est. completion date December 15, 2020

Study information
Verified date February 2020
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact ilker gönen
Phone +905322054822
Email ilkergonen81@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 15, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Hours
Eligibility Inclusion Criteria:

- late preterm and term infants with respiratory distress

Exclusion Criteria:

- intubation for the respiratory distres.

- major abnormalities

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• HHHFNC
noninvasive ventilation modality
• NCPAP
noninvasive ventilation modality
• NIPPV
noninvasive ventilation modality
• NHFO
noninvasive ventilation modality

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Research and Training Hospital Istanbul
Turkey Kanuni Sultan Suleyman Research and Training Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Silverman Score The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman. 6 months
Secondary N-PASS score evaluation of the comfort of the four different noninvasive ventilation modes 6 months
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