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

Acute Mechanical Ventilatory Failure Clinical Trial

— RescueHFO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02752438
• Other study ID #: RescueHFO
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2016
• Last updated: September 12, 2016
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: September 2016
• Source: Ankara University
• Contact: Emel Okulu, Attending
• Phone: 5054812151
• Email: emelokulu[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Mechanical Ventilatory Failure
• Hypoventilation

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara University Children's Hospital	Ankara

Sponsors (11)

Lead Sponsor	Collaborator
Ankara University	Adana Metro Hospital, Celal Bayar University, Etlik Zubeyde Hanim Womens, Gazi University School of Medicine, Gulhane Military Medical Academy, Inonu University Turgut Ozal Health Center, Istanbul Medeniyet University, Izmir Dr. Behçet Uz Children's Hospital, Konya Training and Research Hospital, Zeynep Kamil Maternity and Children's Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		3 months	Yes
Secondary	Cut-off gestational age for survival		3 months	Yes
Secondary	Cut-off birthweight for survival		3 months	Yes