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Ventilation

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

N/A
Recruiting
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
Must not have
Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia), or congenital heart disease requiring intervention in the neonatal period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (total 18 months)
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My infant does not have any birth defects affecting breathing or heart conditions needing early surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of preterm infants receiving the intervention

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
942 Previous Clinical Trials
434,359 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 2025
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