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Comparing Breathing Support for Extremely Premature Babies

This study is looking at two ways to help extremely premature babies (born between 25 and 29 weeks) breathe right after birth. Many of these babies need help with breathing, called positive pressure ventilation (PPV). One method uses a T-piece resuscitator (TPR), which is common. The other method uses a ventilator to provide PPV (V-PPV). Researchers want to see if one method is better at preventing serious problems like death before leaving the hospital, major brain injury, or severe lung disease (BPD). You could be eligible if your baby is born very prematurely and needs breathing support within the first 10 minutes after birth. The study status is currently unclear, and it plans to enroll 780 babies.

Study design
This study is interventional and plans to enroll 780 participants. Each hospital site will be randomly assigned to use either the T-piece resuscitator or ventilator-derived positive pressure ventilation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment through study completion, up to 50 weeks postmenstrual age, and for moderate-severe BPD at 36 weeks' postmenstrual age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06849596

Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates

Recruiting
NAAges 25–29InterventionalTreatment
Michelle Baczynski
~780 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Ventilator derived positive pressure ventilation - V-PPVT-piece resuscitator (TPR)

At a glance

Recruiting sites
7 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite of pre-discharge mortality
Measured over From enrollment through study completion (up to 50 weeks postmenstrual age)
+2 more outcomes measured

Conditions

Neonatal Resuscitation
Apnea Neonatal

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Premature infant

NCT06849596

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • BC Children's and Women's Hospital

    Vancouver, British Columbia, Canadastudy coordinator listed

    Not yet recruiting

  • Cedars-Sinai Guerin Children's

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Children's Hospital at London Health Sciences Centre

    London, Ontario, Canadastudy coordinator listed

    Not yet recruiting

  • CHU Sainte Justine

    Montreal, Quebec, Canadastudy coordinator listed

    Recruiting

  • Foothills Medical Centre

    Calgary, Alberta, Canadastudy coordinator listed

    Recruiting

  • McMaster Children's Hospital

    Hamilton, Ontario, Canadastudy coordinator listed

    Recruiting

  • Montreal Children's Hospital

    Montral, Quebec, Canadastudy coordinator listed

    Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario, Canadastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michelle Baczynski, MSc · PRINCIPAL_INVESTIGATOR · MOUNT SINAI HOSPITAL

Who to contact

Thaiani Wulff, BSc
[email protected]
1-416-586-4800. · ext. 176746
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Composite of pre-discharge mortalityFrom enrollment through study completion (up to 50 weeks postmenstrual age)

    Death in NICU

  • Major neuro-injuryFrom enrollment through study completion (up to 50 weeks postmenstrual age)

    Defined as IVH ≥grade 3, cerebellar hemorrhage or periventricular leukomalacia.

  • Moderate-severe BPDAt 36 weeks' postmenstrual age.

    Defined as 2 L/min nasal cannula or other forms of non-invasive ventilation support or invasive mechanical ventilation.