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

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ClinicalTrials.gov Identifier: NCT03057587
Recruitment Status : Withdrawn (The research never began.)
First Posted : February 20, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Ellen McCann, Boston Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Blood Pressure Device: NIRS Monitoring

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.)

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Newborn Project: A Prospective Observational Study Examining the Oxygenation of Brain Tissue During General Anesthesia Using Near Infrared Spectroscopy Technology
Actual Study Start Date : May 12, 2017
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : April 27, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
NIRS Monitoring
A NIRS sensor will be placed on the forehead of the patient upon entry to the operating room and will remain on, as tolerated, for the duration of surgery
 Device: NIRS Monitoring
NIRS data will be collected throughout the surgery


Outcome Measures
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Primary Outcome Measures :
  1. Cerebral Oxygenation [ Time Frame: Intraoperative period ]
    Determine what factors are correlated with changes in the cerebral oxygenation


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants scheduled to undergo general anesthesia at Boston Children's Hospital
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057587


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Mary Ellen McCann, MD, MPH Boston Children's Hospital
More Information
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Publications:

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Responsible Party: Mary Ellen McCann, MD, MPH, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03057587    
Other Study ID Numbers: IRB-P00021194
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No