Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06849596 · ClinicalTrials.gov registry record · NA
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
A NA study of Neonatal Resuscitation and Apnea Neonatal, sponsored by Michelle Baczynski.
- Recruiting
- Registry status
- NA
- Development phase
- 780
- Enrollment target
- 10
- Study locations
NCT06849596 is a NA study of Neonatal Resuscitation and Apnea Neonatal that is actively recruiting participants, run by Michelle Baczynski. The registered enrollment target is 780 participants, below the 12,385-participant average among 3 other Neonatal Resuscitation trials with a reported enrollment target (94% lower). The trial reports 10 study locations across 6 states.
The verdict
NCT06849596, a NA study of Neonatal Resuscitation and Apnea Neonatal, is actively recruiting participants, sponsored by Michelle Baczynski.
- RECRUITING
- Registry status
- NA
- Development phase
- 780 participants
- Enrollment target
- 10
- Study locations
Study Summary
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. However, T-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of PPV. Improving PPV effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. A novel approach, that may overcome the above limitations and deliver PPV with precise settings through a nasal mask, is to use a ventilator to deliver PPV (V-PPV) using a respiratory mode called nasal intermittent positive pressure ventilation (NIPPV). While NIPPV is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of V-PPV use during immediate post-birth stabilization needs to be studied. Preliminary data from our recent single-center study confirmed the feasibility of using V-PPV for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of T-piece. This promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth stabilization. The primary aim is to evaluate the impact of V-PPV on major health complications or death. This study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.
Conditions Studied
Interventions
- DEVICE Ventilator derived positive pressure ventilation - V-PPV
- DEVICE T-piece resuscitator (TPR)
Study Locations (10)
Ontario
- McMaster Children's Hospital - Hamilton
- Children's Hospital at London Health Sciences Centre - London
- Mount Sinai Hospital - Toronto
Alberta
- Foothills Medical Centre - Calgary
- Royal Alexandra Hospital - Edmonton
Quebec
- Montreal Children's Hospital - Montral
- CHU Sainte Justine - Montreal
California
- Cedars-Sinai Guerin Children's - Los Angeles
British Columbia
- BC Children's and Women's Hospital - Vancouver
Other
- Rigshospitalet Coppenhagen - Copenhagen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 780 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2029-01-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06849596
The ClinicalTrials.gov registry entry for NCT06849596 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 780 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,385-participant average among 3 other Neonatal Resuscitation trials with a reported enrollment target (94% lower). The listed sponsor is Michelle Baczynski, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neonatal Resuscitation appearing as the primary indexed condition, and to 2 interventions - of which Ventilator derived positive pressure ventilation - V-PPV is the first listed.
NCT06849596 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Ontario, Alberta, Quebec.
Frequently Asked Questions
What is clinical trial NCT06849596 about?
NCT06849596 is a clinical study titled "Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates". Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontane...
What is the current status of trial NCT06849596?
This trial is currently recruiting. It is a NA study. The enrollment target is 780 participants. The study started on 2025-12-01. Estimated completion is 2029-01-01.
What conditions does trial NCT06849596 study?
This clinical trial studies the following conditions: Neonatal Resuscitation, Apnea Neonatal.
What interventions are being tested in trial NCT06849596?
The interventions under investigation include: Ventilator derived positive pressure ventilation - V-PPV (DEVICE), T-piece resuscitator (TPR) (DEVICE).
Who is sponsoring clinical trial NCT06849596?
This trial is sponsored by Michelle Baczynski, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06849596 being conducted?
This trial has 10 study locations across California, Alberta, British Columbia, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neonatal Resuscitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.