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Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
NCT06849596 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 780 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michelle Baczynski, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06849596 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Ontario, Alberta, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06849596?
This trial is sponsored by Michelle Baczynski, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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