RECRUITING

Acute Concussion and Melatonin

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.

Official Title

The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion

Quick Facts

Study Start:2023-03-01
Study Completion:2024-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04731974

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient diagnosed with an acute concussion within 72 hours
  2. * Patient greater than 8 and less than 19 years old
  1. * Currently taking psychiatric medication
  2. * Cognitive delay
  3. * Glasgow Coma Score \< 14
  4. * positive findings on head computed tomography
  5. * Any patient with intracranial surgery, pathology or instrumentation (e.g. ventriculoperitoneal shunt, brain tumor etc)
  6. * Use of melatonin within the last week

Contacts and Locations

Study Contact

Jeremy M Root, MD
CONTACT
703-407-6738
jroot@childrensnational.org
Bobbe Thomas, BA
CONTACT
202-222-8775
tbthomas@childrensnational.org

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2024-06-30

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2024-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Concussion, Mild
  • Concussion, Brain
  • Pediatric ALL