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NCT Number: NCT06849596

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 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.

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Key information

Age range

25 week–29 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventilator derived positive pressure ventilation - V-PPV

Device

The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. Ventilator delivered positive pressure ventilation (V-PPV) using a nasal interface will be delivered to the infant in the resuscitation room.

T-piece resuscitator (TPR)

Device

The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. PPV will be provided with a T-piece resuscitator (Neopuff, Fisher & Paykel Healthcare) connected to an appropriately sized face-mask.

Primary outcomes

  1. Composite of pre-discharge mortality

    Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)

    Death in NICU

  2. Major neuro-injury

    Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)

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

  3. Moderate-severe BPD

    Time frame: At 36 weeks' postmenstrual age.

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

Secondary outcomes

  1. Components of the primary outcome

    Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)

    Pre-discharge mortality, major neuro-injury or moderate-severe BPD

  2. Frequency of receipt of advanced cardiopulmonary resuscitation measures

    Time frame: From enrollment to 1 hour post intervention.

    Chest compressions or epinephrine administration for the purpose of resuscitation.

  3. Duration of invasive mechanical ventilation during NICU admission

    Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)

    Total number of days on invasive mechanical ventilation

  4. Discharge on home oxygen

    Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)

    Discharge from the NICU requiring oxygen support at home

  5. Other relevant key prematurity related adverse outcome

    Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)

    Necrotizing enterocolitis ≥ stage 2a, retinopathy of prematurity needing treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Thomas, MSc

CONTACT

[email protected]

416-586-4800 ext. 172060

Thaiani Wulff, BSc

CONTACT

[email protected]

1-416-586-4800. ext. 176746

Sponsors and collaborators

Lead sponsor

Michelle Baczynski

Other

Collaborators

  • BC Women's Hospital & Health Centre
  • Cedars-Sinai Medical Center
  • Foothills Medical Centre
  • London Health Sciences Centre
  • McMaster Children's Hospital
  • Montreal Children's Hospital of the MUHC
  • Royal Alexandra Hospital
  • St. Justine's Hospital
  • Sunnybrook Health Sciences Centre

Registry information

Official study 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

Acronym: MVP

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 27, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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