T-piece versus ventilator breathing support at birth for extremely premature babies
A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 780 (estimated) |
| Ages | 25 Weeks to 29 Weeks |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT06849596 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California and 9 other locations
- Cedars-Sinai Guerin Children's — Los Angeles, California, United States (Recruiting)
- Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (Not_yet_recruiting)
- BC Children's and Women's Hospital — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Recruiting)
- Children's Hospital at London Health Sciences Centre — London, Ontario, Canada (Not_yet_recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- Montreal Children's Hospital — Montral, Quebec, Canada (Recruiting)
- CHU Sainte Justine — Montreal, Quebec, Canada (Recruiting)
- Rigshospitalet Coppenhagen — Copenhagen, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Michelle Baczynski, MSc — Mount Sinai Hospital
- Study coordinator: Thaiani Wulff, BSc
- Email: thaiani.wulff@sinaihealth.ca
- Phone: 1-416-586-4800.
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.