Cerebral Hypoxia
Conditions
Brief summary
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.
Interventions
OTHERClinical algorithm
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors of neurodevelopmental outcome are blinded to targeted vs non-targeted monitoring
Intervention model description
randomized to 2 groups: Targeted NIRS monitoring vs Non-targeted, blinded NIRS monitoring
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Days
Healthy volunteers
No
Inclusion criteria
* Very preterm infants with gestational age at least 23 weeks but less than 29 completed weeks * Less than 6 hours of age
Exclusion criteria
* Skin integrity insufficient to allow placement of NIRS sensors * Decision not to provide full intensive care support * Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurodevelopmental outcome | 22-26 months of age | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | from birth until hospital discharge, an average of 3 months. | Death prior to hospital discharge |
| Retinopathy of prematurity | from birth until hospital discharge, an average of 3 months. | Occurrence of retinopathy of prematurity prior to hospital discharge |
Other
| Measure | Time frame | Description |
|---|---|---|
| Burden of Cerebral hypoxia or hyperoxia | From birth until first 7 days of life | Burden of cerebral hypoxia or hyperoxia from NIRS measures |
Countries
United States
Outcome results
None listed