Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns

Официальное название

Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns - a Multi-centre, International Cluster Randomized Control Trial

Обзор

Newborn infants who require cardiopulmonary resuscitation at birth receive chest compression using a 3-Compression to 1-Ventilation (3:1 C:V) ratio. However, the optimal chest compression technique during cardiopulmonary resuscitation is uncertain and identified as a critical gap in evidence. The International Consensus Statement advises to use the 3:1 C:V ratio based on animal studies, and states that there are no clinical trials to support this approach and called for more research. There continues to be uncertainty about the optimal chest compression technique during cardiopulmonary resuscitation. This trial will compare if in newborn infants with cardiac arrest in the delivery room does providing CC+SI (a new chest compression technique) compared to 3:1 C:V decreases the incidence of all mortality within the initial hospital stay. This will be a multi-centre international cluster randomized trial.

Вмешательства

• Процедура CC+SI (Chest compression during sustained inflation)
  CC+SI (Chest compression during sustained inflation)
• Процедура 3:1 C:V (3:1 Compression:Ventilation ratio)
  3:1 C:V Group (Control group - Standard of Care): Newborns randomized to "3:1 C:V" will receive a CC rate of 90/min and 30 ventilations/min as per current resuscitation guidelines. The PIP used for the 30 inflations will also be 30cmH2O) as per current resuscitation guidelines. Every 60sec, a HR assessment as per neonatal guidelines will be performed to assess if HR is \<60/min - continue CC or \>60/min - stop CC (current standard of care). 3:1 C:V will be continued until ROSC.

Первичные конечные точки

• Neonatal mortality [Срок оценки: 0-40 days after birth]

Критерии участия

Критерии включения

• Newborns with gestational age born between 28 to 43 weeks based on best available obstetrical estimate
• Newborns designated to receive full resuscitation, i.e., parental request or pre-determined decision to provide only comfort care at birth
• No known major congenital or chromosomal malformation. All newborns who meet inclusion criteria will be enrolled as the centres agreed to change their local hospital policy during the trial. The inclusion criteria are designed to be pragmatic and provide useful knowledge translation for most of the patient population in the future.

Критерии исключения

\- Newborns born outside of study centers and transported to centers after delivery.

Sex, race, and ethnicity are not part of the exclusion criteria for this trial, and as such it should represent the combined demographics of all centers involved.

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

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Royal Alexandra Hospital — Edmonton

Идентификаторы

NCT: NCT06577818 · Pro00145624

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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