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

February 21, 2020 updated by: Ilker Gönen, Kanuni Sultan Suleyman Training and Research Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34065
        • Completed
        • Kanuni Sultan Suleyman Research and Training Hospital
      • Istanbul, Turkey
        • Recruiting
        • Kanuni Sultan Suleyman Research and Training Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 hours (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • late preterm and term infants with respiratory distress

Exclusion Criteria:

  • intubation for the respiratory distres.
  • major abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Silverman Score
Time Frame: 6 months
The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N-PASS score
Time Frame: 6 months
evaluation of the comfort of the four different noninvasive ventilation modes
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 18, 2020

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

December 15, 2020

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (ACTUAL)

February 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32342545

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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