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NCT02442141 · ClinicalTrials.gov registry record

Peri-operative NIRS Monitoring In Infants

A clinical trial, sponsored by Children's Hospital of Philadelphia.

Completed
Registry status
76
Enrollment target

NCT02442141: Completed study, sponsored by Children's Hospital of Philadelphia.

NCT02442141 is a clinical trial that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 76 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02442141 has completed, sponsored by Children's Hospital of Philadelphia.

COMPLETED
Registry status
76 participants
Enrollment target

Study Summary

The purpose of this research study is to examine the effects of routine anesthesia on infant brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the brain of infants during surgery. This study will help the investigators detect possible blood flow changes in the brain for infants undergoing anesthesia. A monitor and sensors (NIRS or near-infrared spectroscopy) which use light to measure oxygen levels in the blood will be used. Sensors will rest on the child's skin and record measurements before, during and after the surgery.

Primary Outcome

This data will be obtained by using an FDA-approved NIRS monitor. This device measures regional tissue hemoglobin saturation using combinations of spatially resolved near-infrared spectroscopy and modified Beer-Lambert law approaches, along with measure changes in tissue hemoglobin concentrations; in combination, these measurements allow changes in oxy- and deoxyhemoglobin concentrations in the tissue to be calculated. Data will be recorded prior to induction of anesthesia and throughout the pro

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2015-04-28
Est. Completion 2016-09-27
Children's Hospital of Philadelphia

431 total trials

What the finished NCT02442141 record still lists

NCT02442141 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 76 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02442141 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02442141 about?

NCT02442141 is a clinical study titled "Peri-operative NIRS Monitoring In Infants". The purpose of this research study is to examine the effects of routine anesthesia on infant brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the brain of infants during surgery. This study will help the investigators detect possible blood flow changes in the b...

What is the current status of trial NCT02442141?

This trial is currently completed. The enrollment target is 76 participants. The study started on 2015-04-28. Estimated completion is 2016-09-27.

Who is sponsoring clinical trial NCT02442141?

This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02442141, the US trial registry maintained by the National Library of Medicine. NCT02442141 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.