T-piece versus ventilator breathing support at birth for extremely premature babies
Official title: A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial
Run by Mount Sinai Hospital, Canada · NCT06849596 · Data updated 2026-11-12
This will test whether using a ventilator to give precise nasal positive-pressure breaths at birth helps extremely premature infants (25–28 weeks) breathe better than the standard manual T‑piece resuscitator.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 25 Weeks to 29 Weeks |
| Sex | All |
| Enrollment | 780 (estimated) |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 11 sites (Los Angeles, California and 10 other locations) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | January 1, 2029 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT06849596 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants born at 25+0 to 28+6 weeks gestation at a participating center who are designated for full resuscitation and require positive pressure ventilation within the first 10 minutes of life.
✕Probably not a fit
Babies born outside the participating hospitals, those resuscitated outside a typical delivery room, those with major congenital or chromosomal anomalies, or those already breathing without PPV are not eligible and are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Extremely premature infants (gestational age 25+0 to 28+6 weeks) who require positive pressure ventilation within the first 10 minutes after birth will receive either standard manual T‑piece resuscitation or ventilator-delivered nasal intermittent positive pressure ventilation (V‑PPV) via a nasal mask. Clinical teams at participating hospitals will apply the assigned PPV method during delivery-room resuscitation and record short-term respiratory outcomes such as need for intubation, gas exchange measures, and markers of lung injury. The protocol excludes outborn infants, those with major congenital or chromosomal anomalies, or infants already breathing without PPV. Data will be collected across several North American centers to compare the effectiveness and safety of the two PPV approaches.
Why it matters
Potential benefit: If successful, ventilator-delivered nasal PPV could reduce the need for intubation and lower lung injury and complications in extremely premature infants.
How similar studies have gone: NIPPV is commonly used in neonatal intensive care units and prior studies suggest benefits for preterm respiratory support, but using ventilator-driven NIPPV specifically during immediate delivery-room resuscitation is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:: * GA 25+0 to 28+6 weeks using the best available obstetrical estimate * Designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care * Received PPV as determined by the resuscitation team during the first 10 minutes of birth Exclusion Criteria: * Outborn birth status * Resuscitation performed in unforeseen circumstances outside typical delivery room (e.g., emergency department, antenatal ward) * Known major congenital or chromosomal anomaly * Established spontaneous respiration without receipt of PPV
Where it's running
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Cedars-Sinai Guerin Children's
Los Angeles, California, United States Recruiting -
Foothills Medical Centre
Calgary, Alberta, Canada Recruiting -
Royal Alexandra Hospital
Edmonton, Alberta, Canada Recruiting -
McMaster Children's Hospital
Hamilton, Ontario, Canada Recruiting -
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting -
Montreal Children's Hospital
Montral, Quebec, Canada Recruiting
Show 5 more locations
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CHU Sainte Justine
Montreal, Quebec, Canada Recruiting -
BC Children's and Women's Hospital
Vancouver, British Columbia, Canada Not yet recruiting -
Children's Hospital at London Health Sciences Centre
London, Ontario, Canada Withdrawn -
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Not yet recruiting -
Rigshospitalet Coppenhagen
Copenhagen, Denmark Not yet recruiting
Study contacts
- Principal investigator: Michelle Baczynski, MSc, RRT — Mount Sinai Hospital
- Study coordinator: Thaiani Wulff, BSc
- Email: thaiani.wulff@sinaihealth.ca
- Phone: 1-416-586-4800.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.