NCT02752438

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

April 23, 2016

Last Update Submit

September 12, 2016

Conditions

Acute Mechanical Ventilatory Failure

Keywords

high frequency oscillatory ventilationrescuenewborn

Outcome Measures

Primary Outcomes (1)

  • Survival

    3 months

Secondary Outcomes (2)

  • Cut-off gestational age for survival

    3 months

  • Cut-off birthweight for survival

    3 months

Study Arms (2)

Survived

Patients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation and survived.

Device: HFOV

Death

Patients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation but died.

Device: HFOV

Interventions

HFOVDEVICE

HFOV is a kind of respiratory support with a rate higher than physiological but with lesser volume.

DeathSurvived

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • any congenital anomaly
  • HFOV duration less then 4 h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Children's Hospital

Ankara, Ankara, 06100, Turkey (Türkiye)

RECRUITING

Study Officials

  • Omer Erdeve

    Ankara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emel Okulu, Attending

CONTACT

5054812151emelokulu@gmail.com

Omer Erdeve

CONTACT

5054812151

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Omer Erdeve

Study Record Dates

First Submitted

April 23, 2016

First Posted

April 27, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

No individual data will be shared.

Locations

TU(1)