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

• ClinicalTrials.gov Identifier: NCT03057587
• Recruitment Status: Withdrawn
• First Posted: February 20, 2017
• Last Update Posted: November 14, 2018
• Sponsor: Boston Children's Hospital
• 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
• 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 *

• de Graaff JC, Pasma W, van Buuren S, Duijghuisen JJ, Nafiu OO, Kheterpal S, van Klei WA. Reference Values for Noninvasive Blood Pressure in Children during Anesthesia: A Multicentered Retrospective Observational Cohort Study. Anesthesiology. 2016 Nov;125(5):904-913.
• Aly SA, Zurakowski D, Glass P, Skurow-Todd K, Jonas RA, Donofrio MT. Cerebral tissue oxygenation index and lactate at 24 hours postoperative predict survival and neurodevelopmental outcome after neonatal cardiac surgery. Congenit Heart Dis. 2017 Mar;12(2):188-195. doi: 10.1111/chd.12426. Epub 2016 Nov 10.
• Razlevice I, Rugyte DC, Strumylaite L, Macas A. Assessment of risk factors for cerebral oxygen desaturation during neonatal and infant general anesthesia: an observational, prospective study. BMC Anesthesiol. 2016 Oct 28;16(1):107.
• Michelet D, Arslan O, Hilly J, Mangalsuren N, Brasher C, Grace R, Bonnard A, Malbezin S, Nivoche Y, Dahmani S. Intraoperative changes in blood pressure associated with cerebral desaturation in infants. Paediatr Anaesth. 2015 Jul;25(7):681-8. doi: 10.1111/pan.12671. Epub 2015 Apr 30.

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

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