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Ventilation

Mask Ventilation Techniques for Neonatal Respiratory Distress Syndrome (VOLT Trial)

N/A
Waitlist Available
Led By Georg Schmölzer, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Preterm infants 23-28 weeks' gestation requiring respiratory support at birth will be eligible for the trial
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (total 18 months)
Awards & highlights

VOLT Trial Summary

This trial is comparing two ways of giving respiratory support to preterm infants in the delivery room.

Who is the study for?
This trial is for preterm infants born between 23-28 weeks' gestation who need help breathing at birth. It's open to ELGAN babies (Extremely Low Gestational Age Newborns). Babies with congenital abnormalities affecting breathing, certain heart diseases, or without parental consent are excluded.Check my eligibility
What is being tested?
The study compares two methods of helping premature babies breathe right after birth: volume targeted ventilation and pressure targeted ventilation. Infants will be randomly assigned to one of these two approaches in the delivery room.See study design
What are the potential side effects?
Potential side effects may include difficulty in maintaining stable blood gases and potential injury to the lungs due to either too much pressure or inadequate ventilation, but specific risks will depend on each infant's condition.

VOLT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born between 23-28 weeks and needed help breathing.

VOLT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (total 18 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (total 18 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of preterm infants receiving the intervention

VOLT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Volume Targeted VentilationExperimental Treatment1 Intervention
Positive pressure ventilation will be provided using a set tidal volume
Group II: Pressure guided VentilationActive Control1 Intervention
Positive pressure ventilation will be provided using a set peak inflation pressure

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
900 Previous Clinical Trials
387,610 Total Patients Enrolled
5 Trials studying Respiratory Distress Syndrome
3,379 Patients Enrolled for Respiratory Distress Syndrome
Georg Schmölzer, MD, PhDPrincipal InvestigatorUniversity of Alberta

Media Library

Pressure targeted ventilation (Ventilation) Clinical Trial Eligibility Overview. Trial Name: NCT05144724 — N/A
Respiratory Distress Syndrome Research Study Groups: Volume Targeted Ventilation, Pressure guided Ventilation
Respiratory Distress Syndrome Clinical Trial 2023: Pressure targeted ventilation Highlights & Side Effects. Trial Name: NCT05144724 — N/A
Pressure targeted ventilation (Ventilation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144724 — N/A
~33 spots leftby Aug 2024
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