Treatment guided by cerebral oximetry in newborns receiving invasive mechanical ventilation: study protocol for step one of the SafeBoosC-IIIv randomised clinical trial
Abstract
Background: The use of invasive mechanical ventilation in newborns has several risks, including ventilator-induced lung injury, ventilation-associated pneumonia, and hyperventilation leading to potential brain injury, prolonged hospitalisations, and increased mortality. The SafeBoosC-IIIv trial aims to assess the benefits and harms of treatment guided by cerebral oximetry monitoring in newborns receiving invasive mechanical ventilation within the first 28 days from birth. The SafeBoosC consortium is a global network of neonatologists from multiple neonatal intensive care units worldwide.
Methods: The SafeBoosC-IIIv trial is an investigator-initiated, multinational, randomised, pragmatic, superiority phase III clinical trial. The trial will be conducted in two steps. This is a protocol for step one. The objective of step one is to assess if treatment guided by cerebral oximetry monitoring according to the SafeBoosC treatment guideline compared with usual care in newborns receiving invasive mechanical ventilation increases the number of hospital-free days. The participants will be newborns with a gestational age more than or equal to 28 + 0 weeks, postnatal age less than 28 days, expected to receive invasive mechanical ventilation (intubation) for at least 24 h, and a cerebral oximeter available so monitoring can be started within 6 h after initiation of invasive mechanical ventilation. Exclusion criteria will be suspicion of or confirmed brain injury or congenital heart…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,610 participants or records.
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