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Clinical Decision Rule for Pediatric Intracranial Pathology

This study is currently recruiting participants.
Verified April 2016 by Children's Hospitals and Clinics of Minnesota
Sponsor:
ClinicalTrials.gov Identifier:
NCT02742272
First Posted: April 19, 2016
Last Update Posted: April 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
  Purpose
The purpose of this study is to develop a clinical decision rule for patients seen in the pediatric emergency department for possible intracranial pathology. This a prospective study evaluating patients presenting with headache and migraine. The study is observational and does not impact patient care.

Condition
Migraine Headache Headache

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Clinical Decision Rule to Identify Pediatric Patients With Headache at Low Risk for Intra-cranial Pathology

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Intracranial pathology identified by imaging studies [ Time Frame: within 3 months ]

Estimated Enrollment: 500
Study Start Date: September 2015
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
ED Headache or Migraine Patients
The investigators will perform a prospective cohort study of patients ages 6-18 years presenting to the ED with a complaint of headache or migraine over a 12 month period.

Detailed Description:

Background/Question: A significant number of children who present to the Emergency Department (ED) with headache or migraine undergo head imaging with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). However, there is relatively low yield in imaging neurologically normal patients based on prior studies. The goal of this study is to describe the utilization of head CT or MRI among pediatric ED patients with headache and migraine. The investigators plan to evaluate clinical and examination characteristics of these patients, and use this information to develop a clinical decision rule to help providers predict the risk of finding an abnormality that affects patient treatment.

Design: The investigators will perform a study of all children between 6 and 18 years of age who present to the ED with headache or migraine. At the time of the visit providers will be asked to complete a questionnaire regarding exam and history without making any changes to patient care. The investigators will also contact a sub-group of patients who do not undergo MRI or CT, 12-14 weeks after discharge to ask about subsequent headache care after leaving our facility.

Methods: All children age 6-18 years who present to the ED with a chief complaint of headache or migraine will be eligible for the study. Patients will be excluded if they meet any of the following criteria: trauma within 48 hours, previous neurosurgery (shunt included), known tumor, history of cerebral hemorrhage/ischemia, Sickle Cell Disease, thrombophilia, bleeding disorder or non-English speaker. ED Research Assistants and ED staff physicians and nurse practitioners will screen potential candidates and ask providers to review the inclusion criteria. If the eligibility criteria are met, the provider will complete a standardized data collection form regarding exam and history findings. Patient care will not be impacted or altered. Research Assistants will also provide a Parent Information Sheet (either during the visit, or by mail following the ED visit) to the family of those patients who are enrolled informing them they may be contacted following discharge. Medical records will be reviewed for all eligible patients to obtain information on patient demographics, course of treatment and diagnosis. For those patients who do not have any head CT or MRI performed at their visit, the family will be contacted 12-14 weeks later to determine if they have had subsequent care for their headache. If the family is unable to be reached by phone, the patient chart will be reviewed for any other pertinent visits.

Analysis: For each patient characteristic examined, the investigators will look for a statistically significant difference between those patients who have normal head imaging, and those with abnormal imaging. Using the characteristics that are significantly different, the investigators will develop a clinical decision rule to help providers assess the risk of significant findings in an individual patient. The investigators will also develop a decision tree to help aid providers when deciding which patients need head imaging. A sample of patients will have two independent assessments to allow us to look for evidence of inter‐rater reliability in our questionnaires.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the ED with Headache or Migraine who meet the inclusion criteria and do not meet any exclusion criteria.
Criteria

Inclusion Criteria:

  • Age 6-18 years
  • Chief complaint of headache or migraine

Exclusion Criteria:

  • Exclusion criteria
  • Head trauma within 48 hours
  • Previous neurosurgery (shunt included)
  • Personal history of brain tumor
  • History of stroke or vascular abnormality
  • Sickle Cell Disease
  • Fever (temperature over 38 degrees C)
  Contacts and Locations
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): NCT02742272


Contacts
Contact: Meghan Cain, MD 6128136843 meghan.cain@childrensmn.org
Contact: Kristin Frenn, MPH 6128137104 kristin.frenn@childrensmn.org

Locations
United States, Minnesota
Children's Hopsitals and Clinics of Minnesota Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Meghan Cain, MD    612-813-6843    Meghan.cain@childrensmn.org   
Contact: Kristin Frenn, MPH    612.813.7104    kristin.frenn@childrensmn.org   
Principal Investigator: Meghan Cain, MD         
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Meghan Cain, MD Children's Minnesota
  More Information

Publications:
Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT02742272     History of Changes
Other Study ID Numbers: 1506-076
First Submitted: November 20, 2015
First Posted: April 19, 2016
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases