Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation

Poznan University of Medical Sciences (PUMS)

Status: Completed

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

Treatments: Other: pressure-controlled; Other: volume guarantee

Study type: Interventional

Funder types: Other

Identifiers

NCT04391634

388/16

Details and patient eligibility

About

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.

Full 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).

Enrollment: 25 patients

Sex: All

Ages: 24 to 27 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Mechanical ventilation

Other group

Description:

Preterm infants on mechanical ventilation

Treatment:

Other: pressure-controlled

Other: volume guarantee