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

Официальное название

A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial

Обзор

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.

Вмешательства

• Устройство Ventilator derived positive pressure ventilation - V-PPV
  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.
• Устройство T-piece resuscitator (TPR)
  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.

Первичные конечные точки

• Composite of pre-discharge mortality [Срок оценки: From enrollment through study completion (up to 50 weeks postmenstrual age)]
• Major neuro-injury [Срок оценки: From enrollment through study completion (up to 50 weeks postmenstrual age)]
• Moderate-severe BPD [Срок оценки: At 36 weeks' postmenstrual age.]

Вторичные конечные точки (5)

• Components of the primary outcome [Срок оценки: From enrollment through study completion (up to 50 weeks postmenstrual age)]
• Frequency of receipt of advanced cardiopulmonary resuscitation measures [Срок оценки: From enrollment to 1 hour post intervention.]
• Duration of invasive mechanical ventilation during NICU admission [Срок оценки: From enrollment through study completion (up to 50 weeks postmenstrual age)]
• Discharge on home oxygen [Срок оценки: From enrollment through study completion (up to 50 weeks postmenstrual age)]
• Other relevant key prematurity related adverse outcome [Срок оценки: From enrollment through study completion (up to 50 weeks postmenstrual age)]

Критерии участия

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 8 центров

• Foothills Medical Centre — Calgary
• Royal Alexandra Hospital — Edmonton
• BC Children's and Women's Hospital — Vancouver
• McMaster Children's Hospital — Hamilton
• Children's Hospital at London Health Sciences Centre — London
• Mount Sinai Hospital — Toronto
• Montreal Children's Hospital — Montral
• CHU Sainte Justine — Montreal

США · 1 центр

• Cedars-Sinai Guerin Children's — Los Angeles

Дания · 1 центр

• Rigshospitalet Coppenhagen — Copenhagen

Идентификаторы

NCT: NCT06849596 · CTO 5018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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