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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 belowSelect...
My baby was born between 23-28 weeks and needed help breathing.
VOLT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (total 18 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (total 18 months)
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
886 Previous Clinical Trials
384,728 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born between 23-28 weeks and needed help breathing.My parents did not consent to my participation in this study.My infant does not have any birth defects affecting breathing or heart conditions needing early surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Volume Targeted Ventilation
- Group 2: Pressure guided Ventilation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial include younger individuals under the age of 40?
"As per the enrollment specifications, participants must be between 0 Minutes to 1 Minute of age."
Answered by AI
Are there any slots left in this medical experiment?
"Clinicaltrials.gov informs us that this particular trial, posted on November 15th 2022 and updated October 3rd 2022, has concluded its search for participants at this given time. Nevertheless, there are 179 other trials actively recruiting now."
Answered by AI
Am I eligible to join this research experiment?
"Prerequisites for this medical trial involve the presence of respiratory distress neonatal and a patient age between 0 Minutes to 1 Minute. 100 participants are needed in total."
Answered by AI
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