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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Recruitment Status : Withdrawn (The research never began.)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

Tracking Information
First Submitted Date February 15, 2017
First Posted Date February 20, 2017
Last Update Posted Date November 14, 2018
Actual Study Start Date May 12, 2017
Actual Primary Completion Date April 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2017)
Cerebral Oxygenation [ Time Frame: Intraoperative period ]
Determine what factors are correlated with changes in the cerebral oxygenation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Newborn Project: Examining the Oxygenation of Brain Tissue During General Anesthesia
Official Title The Newborn Project: A Prospective Observational Study Examining the Oxygenation of Brain Tissue During General Anesthesia Using Near Infrared Spectroscopy Technology
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.)

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants scheduled to undergo general anesthesia at Boston Children's Hospital
Condition Blood Pressure
Intervention Device: NIRS Monitoring
NIRS data will be collected throughout the surgery
Study Groups/Cohorts 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
Intervention: Device: NIRS Monitoring
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 9, 2018)
0
Original Estimated Enrollment
 (submitted: February 15, 2017)
200
Actual Study Completion Date April 27, 2018
Actual Primary Completion Date April 27, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 6 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03057587
Other Study ID Numbers IRB-P00021194
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mary Ellen McCann, Boston Children's Hospital
Study Sponsor Boston Children's Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Mary Ellen McCann, MD, MPH Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date November 2018