Comparing Two Different Modes of Ventilation in Pretem Ne... | NCT04191239

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

NCT04191239

Sponsor

Ankara City Hospital Bilkent

Status

Completed

Last Update Posted

Aug 9, 2021Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Newborn Morbidity
Respiratory Failure
Bronchopulmonary Dysplasia
Mechanical Ventilation Complication

Interventions

GE ventilator with two different modes

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Dec 5, 2019

First Submission Date that Met QC Criteria

Dec 5, 2019

First Posted Date

Dec 9, 2019Actual

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

Aug 2, 2021

Last Update Posted Date

Aug 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRVC		Preterm infants with need of mechanical ventilation will receive PRVC mode until extubation	Device: GE ventilator with two different modes
Bilevel VG		Preterm infants with need of mechanical ventilation will receive Bilevel VG mode until extubation	Device: GE ventilator with two different modes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GE ventilator with two different modes	Device	GE ventilator with two different modes	Bilevel VG PRVC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intubation time	Duration of mechanical ventilation	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Oxygen dependency	Need for supplemantal oxygen	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

3 Months

Standard Ages

Child

Study Population

All preterms under 32 weeks and between 800-1200 grams, intubated and ventilated in neonatal intensvie care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara City Hospital		Ankara			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D001997	Bronchopulmonary Dysplasia

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury

Browse Leaves

Not provided

Browse Branches

Not provided