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

Completed

• Conditions: Respiratory Failure; Bronchopulmonary Dysplasia; Newborn Morbidity; Mechanical Ventilation Complication
• Interventions: Device: GE ventilator with two different modes

• Registration Number: NCT04191239
• Lead Sponsor: Ankara City Hospital Bilkent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Status Verified: 2020-01
• Study Start: 2021-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PRVC	GE ventilator with two different modes	Preterm infants with need of mechanical ventilation will receive PRVC mode until extubation
Bilevel VG	GE ventilator with two different modes	Preterm infants with need of mechanical ventilation will receive Bilevel VG mode until extubation

Primary Outcome Measures

Name	Time	Method
Intubation time	8 weeks	Duration of mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Oxygen dependency	8 weeks	Need for supplemantal oxygen

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey