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NCT04191239 Clinical Trial

Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC

Respiratory Failure Clinical Trial

Official title:
Two Different Types of Ventilation in Preterm Neonates; Bilevel Volume Guarantee and Pressure Regulated Volume Control

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04191239
Other study ID # 2019512-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date June 30, 2021

Study information
Verified date January 2020
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured. After that mode will shift to Bilevel Volume Guarantee mode for two hours than clinical and other parameters will be checked again. After this intervention, patients will allocated to PRVC or Bilevel VG group for remaining time.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers
Gender All
Age group N/A to 3 Months
Eligibility Inclusion Criteria: - Need for mechanical ventilation - 800-1200 grams of birthweight - Surfactant received - under 32 weeks of gestational age Exclusion Criteria: No need to intubation Congenital anomalies -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• GE ventilator with two different modes
GE ventilator with two different modes

Locations
Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intubation time Duration of mechanical ventilation 8 weeks
Secondary Oxygen dependency Need for supplemantal oxygen 8 weeks
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