Cerebral Oximetry Monitoring in Preterm Infants

Cerebral Oximetry Monitoring in Preterm Infants

Primary research question

Does cerebral oximetry monitoring in the first 72 hours after birth reduce death or severe brain injury at 36 weeks' postmenstrual age in extremely preterm infants?

Study design

Randomized, phase 3 trial

Population

• Number of patients studied: 1601
• Inclusion criteria: Extremely preterm infants (gestational age, <28 weeks), within 6 hours after birth
• Exclusion criteria: Not specified

Interventions

• Experimental group: Treatment guided by cerebral oximetry monitoring for the first 72 hours after birth
• Control group: Usual care

Primary outcome

Composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age

Secondary outcomes

Death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis

Safety outcomes or Adverse Events

One or more serious adverse events occurred in 85.1% of infants in the oximetry group and 86.5% of infants in the usual-care group. Four serious adverse reactions, all severe skin injuries, occurred in the oximetry group.

Conclusion

Treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care.