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Completed

NCT Number: NCT04391634

Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation

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.

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Urogenital Diseases

Age range

24 week–27 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neonatology at Poznań University of Medical Sciences

Poznan, 60-535, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

volume guarantee

Other

volume guarantee assist-control mechanical ventilation

pressure-controlled

Other

pressure-controlled assist-control mechanical ventilation

Primary outcomes

  1. StO2

    Time frame: 6 hours

    Cerebral oxygenation measured using near-infrared spectroscopy [percent]

  2. Stroke volume

    Time frame: 6 hours

    Stroke volume (SV) monitored with electrical cardiometry [ml]

  3. Cardiac output

    Time frame: 6 hours

    Cardiac output (CO) monitored with electrical cardiometry [L/min]

  4. Stroke index

    Time frame: 6 hours

    Stroke index (SI) monitored with electrical cardiometry [ml/m2]

  5. Cardiac index

    Time frame: 6 hours

    Cardiac index (CI) monitored with electrical cardiometry [L/min/m2]

  6. Stroke volume variation (SVV)

    Time frame: 6 hours

    Stroke volume variation (SVV) monitored with electrical cardiometry [percent]

  7. Index of contractility

    Time frame: 6 hours

    Index of contractility (ICON) monitored with electrical cardiometry

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 18, 2020
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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