Clinical Trials Logo
  1. Home
  2. Neonatal Respiratory Distress
  3. NCT05144724
  4. Details
NCT05144724 Clinical Trial

Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

Neonatal Respiratory Distress Clinical Trial

— VOLT  

Official title:
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05144724
Other study ID # Pro00115050
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2024

Study information
Verified date June 2024
Source University of Alberta
Contact Georg Schmölzer, MD, PhD
Phone +17807354647
Email georg.schmoelzer@me.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room. Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Minutes to 1 Minute
Eligibility Inclusion Criteria: - Preterm infants 23-28 weeks' gestation requiring respiratory support at birth will be eligible for the trial. Inclusion criteria are pragmatic to enable the inclusion of ELGAN infants (Extremely Low Gestational Age Newborns). Exclusion Criteria: - 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. - Infants will also be excluded if their parents refuse to give consent to this study.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Volume targeted ventilation
Positive pressure ventilation will be provided using a set tidal volume
• Pressure targeted ventilation
Positive pressure ventilation will be provided using a set peak inflation pressure

Locations
Country Name City State
Canada Royal Alexandra Hospital Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of preterm infants receiving the intervention Number of Participants who have received allocated treatment Through study completion (total 18 months)
See also
  Status Clinical Trial Phase
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Active, not recruiting NCT04780412 - Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section Phase 3
Completed NCT05257499 - In-person Versus Online Debriefing in HBB N/A
Terminated NCT04096235 - A Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU) N/A
Recruiting NCT05737095 - Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital
Completed NCT06171867 - PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring N/A
Recruiting NCT02030691 - Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress N/A
Not yet recruiting NCT06292338 - Lung Sonar in Neonatal Respiratory Disorders
Not yet recruiting NCT06372951 - Lung Ultrasound in Neonatal Intensive Care Units
Completed NCT06198478 - Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit
Recruiting NCT06356909 - Study of PREMEdication Before Laryngoscopy in Neonates in France
Recruiting NCT03239327 - Vaginal Misoprostol to Improve the Neonatal Respiratory Outcome N/A
Completed NCT04051762 - A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure
Not yet recruiting NCT03899597 - The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section N/A
Recruiting NCT02978976 - Effect of Antenatal Steroid on Pulmonary Artery Blood Flow Phase 4
Completed NCT06285669 - Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants N/A
Recruiting NCT06207994 - PRICO: OPTI Target Range N/A
Recruiting NCT05274386 - Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study N/A
Recruiting NCT02020993 - Urine NT-ProBNP in Neonatal Respiratory Distress N/A
Recruiting NCT04947215 - The Association Between LPCAT1 Genetic Polymorphism and Stress Biomarkers in Neonatal Respiratory Distress Syndrome