Back to resultsCerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation
Primary Purpose
Respiratory Distress Syndrome, Newborn, Respiratory Failure, Premature Birth
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
volume guarantee
pressure-controlled
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn
Eligibility Criteria
Inclusion Criteria:
- premature infants born <28 weeks of gestation
- respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation
- stable condition with pH (acidity of blood)> 7.2 and pCO2 (carbon dioxide partial pressure) <60 mmHg in the blood gas analysis
- no identified genetic syndromes and serious congenital malformations
Exclusion Criteria:
- lack of written consent of patients' parents
Sites / Locations
- Department of Neonatology at Poznań University of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mechanical ventilation
Arm Description
Preterm infants on mechanical ventilation
Outcomes
Primary Outcome Measures
StO2
Cerebral oxygenation measured using near-infrared spectroscopy [percent]
Stroke volume
Stroke volume (SV) monitored with electrical cardiometry [ml]
Cardiac output
Cardiac output (CO) monitored with electrical cardiometry [L/min]
Stroke index
Stroke index (SI) monitored with electrical cardiometry [ml/m2]
Cardiac index
Cardiac index (CI) monitored with electrical cardiometry [L/min/m2]
Stroke volume variation (SVV)
Stroke volume variation (SVV) monitored with electrical cardiometry [percent]
Index of contractility
Index of contractility (ICON) monitored with electrical cardiometry
Secondary Outcome Measures
Full Information
NCT ID
NCT04391634
First Posted
May 7, 2020
Last Updated
May 19, 2020
Sponsor
Poznan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04391634
Brief Title
Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation
Official Title
Cerebral Oxygenation and Circulatory Parameters During Pressure Controlled vs. Volume Targeted Mechanical Ventilation in the Extremely Preterm Infants With Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.
Detailed Description
Prospective, cross-over trial enrolling neonates <28 weeks' gestation requiring MV. Patients were ventilated for 3 hours with pressure controlled assist-control (PC-AC) mode, followed by 3-hours of volume guarantee assist-control ventilation (VG-AC). Continuous monitoring was carried out using pulse oximetry (oxygen saturation - SpO2 and heart rate - HR), near-infrared spectroscopy (cerebral oxygenation - StO2) and electrical cardiometry (circulatory parameters).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn, Respiratory Failure, Premature Birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective crossover study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mechanical ventilation
Arm Type
Other
Arm Description
Preterm infants on mechanical ventilation
Intervention Type
Other
Intervention Name(s)
volume guarantee
Intervention Description
volume guarantee assist-control mechanical ventilation
Intervention Type
Other
Intervention Name(s)
pressure-controlled
Intervention Description
pressure-controlled assist-control mechanical ventilation
Primary Outcome Measure Information:
Title
StO2
Description
Cerebral oxygenation measured using near-infrared spectroscopy [percent]
Time Frame
6 hours
Title
Stroke volume
Description
Stroke volume (SV) monitored with electrical cardiometry [ml]
Time Frame
6 hours
Title
Cardiac output
Description
Cardiac output (CO) monitored with electrical cardiometry [L/min]
Time Frame
6 hours
Title
Stroke index
Description
Stroke index (SI) monitored with electrical cardiometry [ml/m2]
Time Frame
6 hours
Title
Cardiac index
Description
Cardiac index (CI) monitored with electrical cardiometry [L/min/m2]
Time Frame
6 hours
Title
Stroke volume variation (SVV)
Description
Stroke volume variation (SVV) monitored with electrical cardiometry [percent]
Time Frame
6 hours
Title
Index of contractility
Description
Index of contractility (ICON) monitored with electrical cardiometry
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
27 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
premature infants born <28 weeks of gestation
respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation
stable condition with pH (acidity of blood)> 7.2 and pCO2 (carbon dioxide partial pressure) <60 mmHg in the blood gas analysis
no identified genetic syndromes and serious congenital malformations
Exclusion Criteria:
lack of written consent of patients' parents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Szczapa, MD, PhD
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neonatology at Poznań University of Medical Sciences
City
Poznań
ZIP/Postal Code
60-535
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation
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