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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-29
SponsorMichelle Baczynski

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

780 Participants
are divided into 2 treatment groups
Group A: Control group (T-Piece Resuscitator)Active comparator 1 intervention
Group B: Intervention under investigation (Ventilator delivered PPV)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite of pre-discharge mortality

Death in NICU

Time frame
From enrollment through study completion (up to 50 weeks postmenstrual age)
2

Major neuro-injury

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

Time frame
From enrollment through study completion (up to 50 weeks postmenstrual age)
3

Moderate-severe BPD

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

Time frame
At 36 weeks' postmenstrual age.

Secondary outcomes

1

Components of the primary outcome

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

Time frame
From enrollment through study completion (up to 50 weeks postmenstrual age)
2

Frequency of receipt of advanced cardiopulmonary resuscitation measures

Chest compressions or epinephrine administration for the purpose of resuscitation.

Time frame
From enrollment to 1 hour post intervention.
3

Duration of invasive mechanical ventilation during NICU admission

Total number of days on invasive mechanical ventilation

Time frame
From enrollment through study completion (up to 50 weeks postmenstrual age)
4

Discharge on home oxygen

Discharge from the NICU requiring oxygen support at home

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

Other outcomes

Sponsors and contacts

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Michelle Baczynski

Lead sponsor

Mount Sinai Hospital, Canada

Sponsor institution

Royal Alexandra Hospital

Collaborator

Foothills Medical Centre

Collaborator

McMaster Children's Hospital

Collaborator

St. Justine's Hospital

Collaborator

Cedars-Sinai Medical Center

Collaborator

Montreal Children's Hospital of the MUHC

Collaborator

Sunnybrook Health Sciences Centre

Collaborator

BC Women's Hospital & Health Centre

Collaborator

Copenhagen University Hospital, Rigshospitalet

Collaborator