An interventional study of Clinical algorithm in Cerebral Hypoxia, sponsored by Stanford University. Active, not recruiting at 1 site in United States. Open to participants aged Up to 2 Days. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Stanford University · Not applicable, Interventional, and Diagnostic
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.
81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.
Browse Hypoxia, Brain studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to the targeted Csat arm will have NIRS monitoring of cerebral saturations (Csat) and will have algorithm-driven clinical interventions to maintain Csat within target range in the first week of life.
Other: Clinical algorithm
Subjects randomized to the non-targeted Csat arm will have NIRS (near-infrared spectroscopy) monitoring of Csats, but Csat values will be obscured and not available to providers. These subjects will not have any algorithm-driven clinical interventions for Csat.
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.
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.
Burden of Cerebral hypoxia or hyperoxia
Burden of cerebral hypoxia or hyperoxia from NIRS measures
Time frame: From birth until first 7 days of life
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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