Rescue High Frequency Oscillatory Ventilation in Newborns... | NCT02752438

Studies
Rescue High Frequency Oscillatory Ventilation in Newborns Who Do Not Respond to Conventional Ventilation

NCT02752438

Sponsor

Ankara University

Status

Unknown status

Last Update Posted

Sep 13, 2016Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Acute Mechanical Ventilatory Failure

Interventions

HFOV

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

May 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Apr 23, 2016

First Submission Date that Met QC Criteria

Apr 26, 2016

First Posted Date

Apr 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2016

Last Update Posted Date

Sep 13, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Omer Erdeve, Prof. Dr. Omer Erdeve, Ankara UniversityPrincipal Investigator

Lead Sponsor

Ankara UniversityOTHER

Collaborators

Name	Class
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi	OTHER
Etlik Zubeyde Hanim Womens	UNKNOWN
Zeynep Kamil Maternity and Pediatric Research and Training Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
HFOV	Device	HFOV is a kind of respiratory support with a rate higher than physiological but with lesser volume.	Death Survived

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival		3 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

28 Days

Standard Ages

Child

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emel Okulu, Attending	Contact	5054812151		emelokulu@gmail.com
Omer Erdeve	Contact	5054812151

Overall Officials

Name	Affiliation	Role
Omer Erdeve	Ankara University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara University Children's Hospital	Recruiting	Ankara	Ankara	06100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

No individual data will be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided