Cerebral oximetry monitoring in extremely preterm infants does not reduce mortality

1. In this randomized controlled trial, 72 hours of cerebral oximetry monitoring in preterm infants did not significantly reduce mortality or incidence of severe brain injury at 36 weeks.

2. There was no significant difference between cerebral oximetry monitoring and usual care in the incidence of bronchopulmonary dysplasia, retinopathy of prematurity, sepsis, or necrotizing enterocolitis.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Among infants born extremely preterm, the risk of severe neurological injury or death is substantial. Particularly, as their physiology at this stage predisposes them to many risks, including impaired cerebral blood flow, hypoxia, and respiratory distress. It has been suggested in previous studies that monitoring cerebral oxygenation in this population may be helpful in minimizing the risk of damage caused by ischemia. This study used a randomized trial design of 1,601 infants to investigate whether cerebral oxygen monitoring for the first 72 hours in infants born before 28 weeks gestation could reduce the risk of death or survival with severe brain injury. Results of the study found that there was no difference in death or survival with severe brain injury amongst extremely preterm infants randomized to receive cerebral oxygen monitoring and those who received usual care. Although cerebral oxygenation monitoring is a common practice amongst some centers, the results of this study suggest a lack of significant benefit. However, this was a pragmatic trial with optional training for staff participating. Further studies with long-term follow-up, varied or longer duration of oximetry monitoring, and designed with efficacy in mind may help further elucidate the presence or absence of a difference.

Click to read the study in NEJM

In-Depth [randomized controlled trial]: This study was a multinational, phase three, randomized trial evaluating the superiority of cerebral oximetry monitoring for 72 hours after birth in reducing the incidence of death or severe brain injury at 36-weeks amongst extremely preterm infants. The primary outcome was death or survival with severe brain injury at 36-weeks postmenstrual age. Additional outcomes of interest included death at anytime prior, bronchopulmonary dysplasia, severe retinopathy of prematurity, late onset sepsis, necrotizing enterocolitis, focal intestinal perforation, or adverse events associated with the intervention. Infants born earlier than 28-weeks gestation amongst whom it was possible to start cerebral oximetry monitoring within the first six hours after birth were included. In total, 1,601 infants were randomized in a 1:1 ratio to cerebral oximetry monitoring or usual care. Primary results of the study found that there was no significant difference in death or survival with severe brain injury amongst the two groups (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; p=0.64). Similarly, there was no significant difference between the two groups with regards to additional outcome. In summary,  the results of this study suggests that cerebral oximetry monitoring for the first 72-hours of life has no survival benefit at 36-weeks, nor reduced risk of severe brain injury.

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