Neonatal Brain Oxygenation Study

Cerebral Hypoxia Clinical Trial

— BOX  

Official title:

Targeted Cerebral Saturations in Extremely Preterm Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04439968
• Other study ID #: 56759
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hypoxia
• Hypoxia
• Hypoxia, Brain

Intervention

Other:
• Clinical 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.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Burden of Cerebral hypoxia or hyperoxia	Burden of cerebral hypoxia or hyperoxia from NIRS measures	From birth until first 7 days of life
Primary	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.	22-26 months of age
Secondary	Death	Death prior to hospital discharge	from birth until hospital discharge, an average of 3 months.
Secondary	Retinopathy of prematurity	Occurrence of retinopathy of prematurity prior to hospital discharge	from birth until hospital discharge, an average of 3 months.