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

Not Applicable

• Conditions: Respiratory Disease; Respiratory Insufficiency
• Interventions: Device: HHHFNC; Device: NCPAP; Device: NIPPV; Device: NHFO

• Registration Number: NCT04282369
• Lead Sponsor: 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

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-17
• Study Start: 2020-02-18
• Study First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Study First Posted: 2020-02-24
• Last Update Posted: 2020-02-24
• Primary Completion: 2020-08-01
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• late preterm and term infants with respiratory distress

Read More

Exclusion Criteria

• intubation for the respiratory distres.
• major abnormalities

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HHFNC	HHHFNC	In this group patients will receive respiratory support by high flow nasal cannula.
nCPAP	NCPAP	In this group patients will receive respiratory support by nasal CPAP.
nIPPV	NIPPV	In this group patients will receive respiratory support by nasal IPPV.
nHFO	NHFO	In this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation.

Primary Outcome Measures

Name	Time	Method
Silverman Score	6 months	The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.

Secondary Outcome Measures

Name	Time	Method
N-PASS score	6 months	evaluation of the comfort of the four different noninvasive ventilation modes

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Research and Training Hospital; 🇹🇷 Istanbul, Turkey