Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT07060105
Eligibility Criteria:
Inclusion Criteria:
1. Age 8-17
2. Blunt head injury within the past five days with any associated symptoms as outlined in the concussion inventory.
3. English or Spanish speaking.
4. Glasgow Coma Scale score of 13-15
5. Treating provider plans to use saline administration as part of patient's treatment plan
Exclusion Criteria:
1. Intracranial injury diagnosed by CT / MR Brain, though imaging is not a requirement for this study.
2. Possible or witnessed posttraumatic seizure
3. Developmental delay / intellectual disability
4. Underlying cardiac, pulmonary, and renal pathology in which fluid administration or hypertonic saline may potentially be harmful, based on attending provider judgement.
5. Suspected use of alcohol or illicit substances
6. Associated injuries requiring the use of narcotics for analgesia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT07060105
Study Brief:
Protocol Section:
NCT07060105