NCT04391634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

May 7, 2020

Last Update Submit

May 19, 2020

Conditions

Respiratory Distress Syndrome, NewbornRespiratory FailurePremature Birth

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (1)

Mechanical ventilation

OTHER

Preterm infants on mechanical ventilation

Other: volume guaranteeOther: pressure-controlled

Interventions

volume guaranteeOTHER

volume guarantee assist-control mechanical ventilation

Mechanical ventilation
pressure-controlledOTHER

pressure-controlled assist-control mechanical ventilation

Mechanical ventilation

Eligibility Criteria

Age24 Weeks - 27 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • lack of written consent of patients' parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology at Poznań University of Medical Sciences

Poznan, 60-535, Poland

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornRespiratory InsufficiencyPremature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Tomasz Szczapa, MD, PhD

    Poznan University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 18, 2020

Study Start

August 1, 2017

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

PL(1)