Recruiting

Observational Study

Sponsor:

Children's Hospitals and Clinics of Minnesota

Code:

NCT02742272

Conditions

Migraine Headache

Headache

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Migraine Headache

Headache

Study ID

NCT02742272

Start date

Sep, 2015

Status verified date

Apr, 2016

Completion date

Jul, 2016

Anticipated

Primary completion date

Jul, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Meghan Cain, MD

6128136843meghan.cain@childrensmn.org

Kristin Frenn, MPH

6128137104kristin.frenn@childrensmn.org

Locations

Children's Hopsitals and Clinics of Minnesota

Recruiting

St. Paul, Minnesota, United States, 55102

Contacts

Meghan Cain, MD

612-813-6843Meghan.cain@childrensmn.org

Kristin Frenn, MPH

612.813.7104kristin.frenn@childrensmn.org

Principal Investigator:

Meghan Cain, MD

More Information

Sponsor

Children's Hospitals and Clinics of Minnesota

Last update posted

Apr 19, 2016

Last verified

Apr, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota on 2016-04-19.