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

• Sponsor: Ankara City Hospital Bilkent (Other)
• Overall Status: Completed
• CT.gov ID: NCT04191239
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Newborn Morbidity; Respiratory Failure; Bronchopulmonary Dysplasia; Mechanical Ventilation Complication	Device: GE ventilator with two different modes

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Two Different Types of Ventilation in Preterm Neonates; Bilevel Volume Guarantee and Pressure Regulated Volume Control
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
PRVC Preterm infants with need of mechanical ventilation will receive PRVC mode until extubation	Device: GE ventilator with two different modes; 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; GE ventilator with two different modes

Outcome Measures

Primary Outcome Measures

1. Intubation time [8 weeks]

   Duration of mechanical ventilation

Secondary Outcome Measures

1. Oxygen dependency [8 weeks]

   Need for supplemantal oxygen

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 3 Months
• Sexes Eligible for Study: All

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

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara City Hospital	Ankara		Turkey

Sponsors and Collaborators

• Ankara City Hospital Bilkent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ankara City Hospital Bilkent
• ClinicalTrials.gov Identifier: NCT04191239
• Other Study ID Numbers: 2019512-2
• First Posted: Dec 9, 2019
• Last Update Posted: Aug 9, 2021
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Insufficiency; Bronchopulmonary Dysplasia

Study Results

No Results Posted as of Aug 9, 2021