Rescue High Frequency Oscillatory Ventilation in Newborns Who Do Not Respond to Conventional Ventilation (RescueHFO)

September 12, 2016 updated by: Omer Erdeve, Ankara University
Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature.

The aim of the study is to define the factors that affect the success of HFOV in newborns who do not respond to conventional mechanical ventilation through an online registry among neonatal intensive care units in Turkey.

Study Type

Observational

Enrollment (Anticipated)

400

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
      • Ankara, Turkey, 06100
        • Recruiting
        • Ankara University Children's 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

1 day to 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Newborns with respiratory insufficiency in spite of conventional mechanical ventilation are candidates for the study. When the patient is switched to HFOV for rescue respiratory support, he/she will be followed and registered to online registry system.

Description

Inclusion Criteria:

  • patients switched to HFOV in case of unresponse to conventional ventilation
  • stay on HFOV for at least 4 h

Exclusion Criteria:

  • any congenital anomaly
  • HFOV duration less then 4 h

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Survived
Patients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation and survived.
Device: HFOV
HFOV is a kind of respiratory support with a rate higher than physiological but with lesser volume.
Death
Patients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation but died.
Device: HFOV
HFOV is a kind of respiratory support with a rate higher than physiological but with lesser volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cut-off gestational age for survival
Time Frame: 3 months
3 months
Cut-off birthweight for survival
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Ankara University

Collaborators

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Gazi University
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Inonu University
Istanbul Medeniyet University
Celal Bayar University
Konya Meram State Hospital
Dr. Behcet Uz Children's Hospital
Etlik Zubeyde Hanim Womens
Special Metro Hospital

Investigators

  • Principal Investigator: Omer Erdeve, Ankara University

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

May 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

April 23, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (ESTIMATE)

April 27, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RescueHFO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual data will be shared.

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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