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Neonatal Brain Oxygenation Study

NCT04439968 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

  • Cerebral Hypoxia

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
2 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-10
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04439968 on ClinicalTrials.gov