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

NCT ID: NCT04282369

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-18

Study Completion Date

2020-12-15

Brief Summary

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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

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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.

Conditions

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Respiratory Disease Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HHFNC

In this group patients will receive respiratory support by high flow nasal cannula.

Group Type ACTIVE_COMPARATOR

HHHFNC

Intervention Type DEVICE

noninvasive ventilation modality

nCPAP

In this group patients will receive respiratory support by nasal CPAP.

Group Type ACTIVE_COMPARATOR

NCPAP

Intervention Type DEVICE

noninvasive ventilation modality

nIPPV

In this group patients will receive respiratory support by nasal IPPV.

Group Type ACTIVE_COMPARATOR

NIPPV

Intervention Type DEVICE

noninvasive ventilation modality

nHFO

In this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation.

Group Type ACTIVE_COMPARATOR

NHFO

Intervention Type DEVICE

noninvasive ventilation modality

Interventions

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HHHFNC

noninvasive ventilation modality

Intervention Type DEVICE

NCPAP

noninvasive ventilation modality

Intervention Type DEVICE

NIPPV

noninvasive ventilation modality

Intervention Type DEVICE

NHFO

noninvasive ventilation modality

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* late preterm and term infants with respiratory distress

Exclusion Criteria

* intubation for the respiratory distres.
* major abnormalities
Maximum Eligible Age

2 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ilker Gönen

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Suleyman Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status COMPLETED

Kanuni Sultan Suleyman Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ilker gönen

Role: CONTACT

+905322054822

Facility Contacts

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ilker gönen

Role: primary

+905322054822

Other Identifiers

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32342545

Identifier Type: -

Identifier Source: org_study_id

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