Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation

Study Overview
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Brief Summary
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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
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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).

Official Title
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Cerebral Oxygenation and Circulatory Parameters During Pressure Controlled vs. Volume Targeted Mechanical Ventilation in the Extremely Preterm Infants With Respiratory Distress Syndrome

Conditions
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Respiratory Distress Syndrome, Newborn, Respiratory Failure, Premature Birth

Intervention / Treatment
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* Other: volume guarantee
* Other: pressure-controlled


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 27 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mechanical ventilation<br>Preterm infants on mechanical ventilation | Other: volume guarantee<br>* volume guarantee assist-control mechanical ventilation<br>Other: pressure-controlled<br>* pressure-controlled assist-control mechanical ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| StO2 | Cerebral oxygenation measured using near-infrared spectroscopy [percent] | 6 hours | 
| Stroke volume | Stroke volume (SV) monitored with electrical cardiometry [ml] | 6 hours | 
| Cardiac output | Cardiac output (CO) monitored with electrical cardiometry [L/min] | 6 hours | 
| Stroke index | Stroke index (SI) monitored with electrical cardiometry [ml/m2] | 6 hours | 
| Cardiac index | Cardiac index (CI) monitored with electrical cardiometry [L/min/m2] | 6 hours | 
| Stroke volume variation (SVV) | Stroke volume variation (SVV) monitored with electrical cardiometry [percent] | 6 hours | 
| Index of contractility | Index of contractility (ICON) monitored with electrical cardiometry | 6 hours |