Implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral saturations (Csat) using near-infrared spectroscopy (NIRS). Infants will be randomized to a targeted cerebral saturation monitoring group with visible reading of Csat or to a control group with cerebral saturation monitoring, but with blinded Csat measures. Those in the targeted Csat group will follow a treatment guideline to maintain cerebral oxygenation in the target range. The primary outcome is neurodevelopmental outcome as determined by Bayley III cognitive scale score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
100
In order to maintain cerebral saturations within targeted range, subjects in the targeted Csat arm will undergo clinical interventions based on clinical algorithm. Interventions may include administration of inotropes, fluid resuscitation, transfusion of blood products, and/or adjustment to respiratory support.
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
Neurodevelopmental outcome
Neurodevelopmental outcomes will be assessed using the cognitive component of the Bayley Scales of Infant Development-III at 22-26 months of age. Scores range from 55-145 with higher number representing a better neurodevelopmental outcome.
Time frame: 22-26 months of age
Death
Death prior to hospital discharge
Time frame: from birth until hospital discharge, an average of 3 months.
Retinopathy of prematurity
Occurrence of retinopathy of prematurity prior to hospital discharge
Time frame: from birth until hospital discharge, an average of 3 months.
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