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

NCT ID: NCT04191239

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Newborn Morbidity Respiratory Failure Bronchopulmonary Dysplasia Mechanical Ventilation Complication

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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PRVC

Preterm infants with need of mechanical ventilation will receive PRVC mode until extubation

GE ventilator with two different modes

Intervention Type DEVICE

GE ventilator with two different modes

Bilevel VG

Preterm infants with need of mechanical ventilation will receive Bilevel VG mode until extubation

GE ventilator with two different modes

Intervention Type DEVICE

GE ventilator with two different modes

Interventions

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GE ventilator with two different modes

GE ventilator with two different modes

Intervention Type DEVICE

Eligibility Criteria

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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

\-
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019512-2

Identifier Type: -

Identifier Source: org_study_id

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