Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation

NCT ID: NCT04391634

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-05-30

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).

Conditions

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Respiratory Distress Syndrome, Newborn Respiratory Failure Premature Birth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective crossover study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mechanical ventilation

Preterm infants on mechanical ventilation

Group Type OTHER

volume guarantee

Intervention Type OTHER

volume guarantee assist-control mechanical ventilation

pressure-controlled

Intervention Type OTHER

pressure-controlled assist-control mechanical ventilation

Interventions

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volume guarantee

volume guarantee assist-control mechanical ventilation

Intervention Type OTHER

pressure-controlled

pressure-controlled assist-control mechanical ventilation

Intervention Type OTHER

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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

27 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomasz Szczapa, MD, PhD

Role: STUDY_CHAIR

Poznan University of Medical Sciences

Locations

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Department of Neonatology at Poznań University of Medical Sciences

Poznan, , Poland

Site Status

Countries

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Poland

Other Identifiers

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388/16

Identifier Type: -

Identifier Source: org_study_id

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