The Newborn Project: Examining the Oxygenation of Brain Tissue During General Anesthesia

The Newborn Project: A Prospective Observational Study Examining the Oxygenation of Brain Tissue During General Anesthesia Using Near Infrared Spectroscopy Technology

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03057587

Enrollment

Registered

2017-02-20

Start date

2017-05-12

Completion date

2018-04-27

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Brief summary

This study will be an observational, prospective trial that will measure the cerebral oxygenation of infants scheduled to undergo general anesthesia at Boston Children's Hospital.

Detailed description

Data will be collected from the Near Infrared Spectroscopy (NIRS) monitor and the patient's medical record. When the NIRS sensor is attached to the patient's forehead the oxygenation of brain tissue will be continuously monitored. All other information will be routinely recorded as standard clinical care and this information will be obtained from the patient's medical record. The NIRS monitor data will by time synched to the anesthesia record and downloaded to a secured password protected file. In the post-operative period, patient data will be collected including: 1) any skin findings related to the placement of the NIRS or pulse oximetry probes 2) any unanticipated need for hemodynamic support, 3) laboratory values including hemoglobin levels, electrolytes, and blood gases, 4) new neurological findings (seizures etc.)

Interventions

DEVICENIRS Monitoring

NIRS data will be collected throughout the surgery

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

Inclusion criteria

* Children less than 6 months of age * Undergoing a scheduled or emergent procedure with anesthesia at Boston Children's Hospital

Exclusion criteria

* Placement of NIRS sensor that will interfere with surgery * Child has an allergy to medical grade adhesives or pre-existing skin irritation at the sensor site * Scheduled for a cardiac procedure * Patient's care team or patient's family declines participation * American Society of Anesthesiologists (ASA) criteria of IV or greater * Infants who are being treated with sympathomimetic medications intraoperatively

Design outcomes

Primary

Measure	Time frame	Description
Cerebral Oxygenation	Intraoperative period	Determine what factors are correlated with changes in the cerebral oxygenation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026