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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL150229-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. Therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. The trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the Sleep Disturbances Scale for Children 1-month after hospital discharge.
Participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. Participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. Outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. The investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). Exploratory outcomes will include global health outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | (melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin | Drug | melatonin supplementation |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Disturbances Scale for Children | Sleep Disturbances Scale for Children (SDSC): 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5 for a range of possible total scores of 26 - 130. Raw scores are converted to measure defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating worse dysfunction, and T-scores greater than 60 generally indicating clinically significant dysfunction in the total score and all 6 subscale scores. The subscales include Initiation and Maintenance, Arousal, Breathing, Transition, Somnolence, and Hyperhidrosis. | 1-month |
| Recruitment | Quantitative number of patients consented per patients approached | through study completion, an average of 6-months |
| Retention | Quantitative number of participants completing trial procedures per patients consented | through study completion, an average of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence Quantitative | pill counts, report of using study medication at least 5/7 days per week | 1-month |
| Adherence Qualitative | participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Reason for Non-adherence | qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan | 1-month |
| Health Related Quality of Life | Pediatric Quality of Life Inventory (PedsQL): parent reported measure of quality of life. Scores range 0-100 with higher scores indicating better quality of life. |
Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Cydni Williams, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32328648 | Background | Luther M, Poppert Cordts KM, Williams CN. Sleep disturbances after pediatric traumatic brain injury: a systematic review of prevalence, risk factors, and association with recovery. Sleep. 2020 Oct 13;43(10):zsaa083. doi: 10.1093/sleep/zsaa083. | |
| 31797275 | Background | Poppert Cordts KM, Hall TA, Hartman ME, Luther M, Wagner A, Piantino J, Guilliams KP, Guerriero RM, Jara J, Williams CN. Sleep Measure Validation in a Pediatric Neurocritical Care Acquired Brain Injury Population. Neurocrit Care. 2020 Aug;33(1):196-206. doi: 10.1007/s12028-019-00883-5. |
| Label | URL |
|---|---|
| Principal Investigator program website that will be updated regularly for PI contact information and study related materials | View source |
Not provided
Basic tabular results will be entered into clinicaltrials.gov within 1 year of primary completion of the study. We will make participant data available to researchers once thoroughly de-identified and approved by our institutional review board within 1 year of study completion. Data will be made available on requests made directly to the Principal Investigator.
The study protocol and SAP will be shared upon approval by the Institutional Review Board, and the final approved study protocol and SAP with documentation of any amendments will be available at study completion. The ICF will be shared no later than 60days from enrollment of the last study visit. A CSR and analytic code for the primary outcomes analysis will be made available within 1 year of study completion.
Requests for data can be made by contacting the Principal Investigator
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21 of 53 eligible and approached participants recruited between January 2, 2023 and March 1, 2025. All participants were recruited during hospitalization for traumatic brain injury.
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| ID | Title | Description |
|---|---|---|
| FG000 | Melatonin | (melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days) melatonin: melatonin supplementation |
| FG001 | Placebo | Placebo placebo: microcrystalline cellulose filled capsule |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Melatonin | (melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days) melatonin: melatonin supplementation |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Disturbances Scale for Children | Sleep Disturbances Scale for Children (SDSC): 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5 for a range of possible total scores of 26 - 130. Raw scores are converted to measure defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating worse dysfunction, and T-scores greater than 60 generally indicating clinically significant dysfunction in the total score and all 6 subscale scores. The subscales include Initiation and Maintenance, Arousal, Breathing, Transition, Somnolence, and Hyperhidrosis. | Posted | Median | Inter-Quartile Range | T-score | 1-month |
|
30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melatonin | melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days; this arm is not separated by dose administered as all patients received weight based dosing per standard practice in pediatrics melatonin: melatonin supplementation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission to hospital | Nervous system disorders | Systematic Assessment | Patient readmitted to hospital for injury related complications, deemed not related to study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
Pilot trial with small number of participants recruited. Results focus on feasibility, was not powered to detect differences in sleep and other secondary outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cydni Williams | Oregon Health & Science University | 5034945522 | willicyd@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2024 | May 21, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2024 | May 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
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| Other |
microcrystalline cellulose filled capsule |
|
| 1-month |
| Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL MFS); 18 item parent proxy report of fatigue using a likert scale. Responses to each question receive a score of 0, 25,50,75, or 100. The measure provides a total score and three subscale scores- General, Sleep/rest, and Cognitive fatigue subscales based on the average response to each question for the total score and the average response to each subscale's questions for the subscale scores. All scores (total and subscale) range 0-100 with higher scores indicating better function and less fatigue. | 1-month |
| Chronotype | Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Morningness/Eveningness Scale Score summed from responses, range 10 (morningness) to 49 (eveningness) | 1-month |
| Sleep Latency | actigraphy measured time in minutes to fall asleep | 1-month |
| Total Sleep Time | actigraphy measured total time asleep in minutes | 1-month |
| Wake After Sleep Onset | actigraphy measured time in minutes awake after sleep onset | 1-month |
| Number of Night Awakenings | actigraphy measured number of instances awoken after sleep onset | 1-month |
| Sleep Efficiency | actigraphy measure percentage of nighttime period spent asleep | 1-month |
| Sleep Onset Time | time of day fell asleep presented as hours corresponding the the time of day from midnight as 0 hours (e.g., 22.5 hours means they fell asleep at 10:30 pm) | 1-month |
| Sleep Offset Time | time of day waking from nighttime sleep presented in hours from midnight as time 0 (e.g., 7.5 hours means they woke up at 7:30 am) | 1-month |
| Adverse Events Time 0 | Evaluation of adverse events asking participants to report any side effects of study interventions; Number of patients with any adverse event reported or noted on symptom screening checklist | hospital discharge assessed up to 7 days |
| Adverse Events Time 1 | Evaluation of adverse events asking participants to report any side effects of study interventions | 1-month |
| 1-month |
| Cognitive Functioning | Behavior Rating Inventory of Executive Function, second edition (BRIEF-2); parent proxy report of everyday executive function, reported as standardized Global Executive Composite T-score, with higher scores indicating worse function. T-scores range from 0-100, with a mean of 50 and standard deviation of 10. | 1-month |
| Physical Functioning | Functional Status Scale, range 6-30, with higher scores indicating worse function; measured at followup | 1-month |
| Anxiety | Patient Reported Outcome Measurement Information System (PROMIS) anxiety short form T-score with higher scores indicating worse outcome. T-scores range from 0 - 100, with a mean of 50 and standard deviation of 10. | 1-month |
| Depression | Patient Reported Outcome Measurement Information System (PROMIS) depression short form T-score with higher scores indicating worse outcome. T-scores range from 0-100, with a mean of 50 and standard deviation of 10. | 1-month |
| PROMIS Pain Behavior | Patient Reported Outcome Measurement Information System (PROMIS) pain behavior (T-score with mean of 50 and standard deviation of 10) parent report forms; Higher scores indicate worse pain outcomes | 1-month |
| 31735567 | Background | Williams CN, Hartman ME, McEvoy CT, Hall TA, Lim MM, Shea SA, Luther M, Guilliams KP, Guerriero RM, Bosworth CC, Piantino JA. Sleep-Wake Disturbances After Acquired Brain Injury in Children Surviving Critical Care. Pediatr Neurol. 2020 Feb;103:43-51. doi: 10.1016/j.pediatrneurol.2019.08.010. Epub 2019 Aug 26. |
Placebo
placebo: microcrystalline cellulose filled capsule
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Medicaid Insurance Status | Count of Participants | Participants |
|
| Admission Glasgow Coma Scale Score | Count of Participants | Participants |
|
| Pre-injury medical condition present | Count of Participants | Participants |
|
| Pre-injury psychological diagnosis present | Count of Participants | Participants |
|
| Pre-injury neurodevelopmental condition present | Count of Participants | Participants |
|
| Skull fracture present at admission | Count of Participants | Participants |
|
| Intracranial injury on imaging present at admission | Count of Participants | Participants |
|
| Other injuries (non-brain) present at admission | Count of Participants | Participants |
|
| Inpatient Rehabilitation Discharge Disposition | Count of Participants | Participants |
|
| Sleep Disturbances Scale for Children Total score | Sleep Disturbances Scale for Children: 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5 for a range of possible total scores of 26 - 130. Raw scores are converted to measured defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating dysfunction, and T-scores greater than 60 generally indicating clinically significant dysfunction. | Median | Inter-Quartile Range | T-score |
|
| Sleep Disturbances Scale for Children Initiation and Maintenance Subscale | Sleep Disturbances Scale for Children: 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5. Raw scores are converted to measured defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating dysfunction. T-scores greater than 60 generally indicating clinically significant dysfunction. The Disorders of Initiation and Maintenance Subscale evaluates potential disorders like insomnia or circadian rhythm disturbances. | Median | Inter-Quartile Range | T-score |
|
| Sleep Disturbances Scale for Children Breathing Subscale | Sleep Disturbances Scale for Children: 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5. Raw scores are converted to measured defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating dysfunction. T-scores greater than 60 generally indicating clinically significant dysfunction. The Breathing Subscale evaluates potential disorders like sleep apnea. | Median | Inter-Quartile Range | T-score |
|
| Sleep Disturbances Scale for Children Arousal Subscale | Sleep Disturbances Scale for Children: 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5. Raw scores are converted to measured defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating dysfunction. T-scores greater than 60 generally indicating clinically significant dysfunction. The Arousal subscale evaluates potential disorders like sleepwalking and night terrors. | Median | Inter-Quartile Range | T-score |
|
| Sleep Disturbances Scale for Children Sleep Wake Transition Subscale | Sleep Disturbances Scale for Children: 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5. Raw scores are converted to measured defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating dysfunction. T-scores greater than 60 generally indicating clinically significant dysfunction. The sleep wake transition subscale evaluates potential disorders like sleep talking or sleep movement disorders. | Median | Inter-Quartile Range | T-score |
|
| Sleep Disturbances Scale for Children Somnolence Subscale | Sleep Disturbances Scale for Children: 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5. Raw scores are converted to measured defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating dysfunction. T-scores greater than 60 generally indicating clinically significant dysfunction. The somnolence subscale evaluates potential disorders of excessive sleepiness or narcolepsy. | Median | Inter-Quartile Range | T-score |
|
| Sleep Disturbances Scale for Children Hyperhidrosis Subscale | Sleep Disturbances Scale for Children: 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5. Raw scores are converted to measured defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating dysfunction. T-scores greater than 60 generally indicating clinically significant dysfunction. The hyperhidrosis subscale evaluates excessive sweating during sleep. | Median | Inter-Quartile Range | T-score |
|
| OG001 | Placebo | Placebo placebo: microcrystalline cellulose filled capsule |
|
|
| Primary | Recruitment | Quantitative number of patients consented per patients approached | Number of eligible patients approached for consent | Posted | Count of Participants | Participants | through study completion, an average of 6-months |
|
|
|
| Primary | Retention | Quantitative number of participants completing trial procedures per patients consented | Posted | Count of Participants | Participants | through study completion, an average of 30 days |
|
|
|
| Secondary | Adherence Quantitative | pill counts, report of using study medication at least 5/7 days per week | Posted | Count of Participants | Participants | 1-month |
|
|
|
| Secondary | Adherence Qualitative | participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention | Posted | Count of Participants | Participants | 1-month |
|
|
|
| Secondary | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL MFS); 18 item parent proxy report of fatigue using a likert scale. Responses to each question receive a score of 0, 25,50,75, or 100. The measure provides a total score and three subscale scores- General, Sleep/rest, and Cognitive fatigue subscales based on the average response to each question for the total score and the average response to each subscale's questions for the subscale scores. All scores (total and subscale) range 0-100 with higher scores indicating better function and less fatigue. | Posted | Median | Inter-Quartile Range | score on a scale | 1-month |
|
|
|
| Secondary | Chronotype | Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Morningness/Eveningness Scale Score summed from responses, range 10 (morningness) to 49 (eveningness) | Posted | Median | Inter-Quartile Range | score on a scale | 1-month |
|
|
|
| Secondary | Sleep Latency | actigraphy measured time in minutes to fall asleep | Actigraphy usable providing 5/7 days per week of data | Posted | Median | Inter-Quartile Range | minutes | 1-month |
|
|
|
| Secondary | Total Sleep Time | actigraphy measured total time asleep in minutes | Actigraphy usable data if 5/7 days per week | Posted | Median | Inter-Quartile Range | minutes | 1-month |
|
|
|
| Secondary | Wake After Sleep Onset | actigraphy measured time in minutes awake after sleep onset | Posted | Median | Inter-Quartile Range | minutes | 1-month |
|
|
|
| Secondary | Number of Night Awakenings | actigraphy measured number of instances awoken after sleep onset | Posted | Median | Inter-Quartile Range | number of awakenings | 1-month |
|
|
|
| Secondary | Sleep Efficiency | actigraphy measure percentage of nighttime period spent asleep | Posted | Median | Inter-Quartile Range | percentage of time in bed deemed asleep | 1-month |
|
|
|
| Secondary | Sleep Onset Time | time of day fell asleep presented as hours corresponding the the time of day from midnight as 0 hours (e.g., 22.5 hours means they fell asleep at 10:30 pm) | Posted | Median | Inter-Quartile Range | hours corresponding to time of day | 1-month |
|
|
|
| Secondary | Sleep Offset Time | time of day waking from nighttime sleep presented in hours from midnight as time 0 (e.g., 7.5 hours means they woke up at 7:30 am) | Posted | Median | Inter-Quartile Range | hours corresponding to time of day | 1-month |
|
|
|
| Secondary | Adverse Events Time 0 | Evaluation of adverse events asking participants to report any side effects of study interventions; Number of patients with any adverse event reported or noted on symptom screening checklist | Posted | Count of Participants | Participants | hospital discharge assessed up to 7 days |
|
|
|
| Secondary | Adverse Events Time 1 | Evaluation of adverse events asking participants to report any side effects of study interventions | Not Posted | 1-month | Participants |
| Other Pre-specified | Reason for Non-adherence | qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan | Reasons given for not using study medication every night or sleep plan resources at any frequency | Posted | Count of Participants | Participants | 1-month |
|
|
|
| Other Pre-specified | Health Related Quality of Life | Pediatric Quality of Life Inventory (PedsQL): parent reported measure of quality of life. Scores range 0-100 with higher scores indicating better quality of life. | Posted | Median | Inter-Quartile Range | score on a scale | 1-month |
|
|
|
| Other Pre-specified | Cognitive Functioning | Behavior Rating Inventory of Executive Function, second edition (BRIEF-2); parent proxy report of everyday executive function, reported as standardized Global Executive Composite T-score, with higher scores indicating worse function. T-scores range from 0-100, with a mean of 50 and standard deviation of 10. | Posted | Median | Inter-Quartile Range | T-score on a scale | 1-month |
|
|
|
| Other Pre-specified | Physical Functioning | Functional Status Scale, range 6-30, with higher scores indicating worse function; measured at followup | Posted | Median | Inter-Quartile Range | score on a scale | 1-month |
|
|
|
| Other Pre-specified | Anxiety | Patient Reported Outcome Measurement Information System (PROMIS) anxiety short form T-score with higher scores indicating worse outcome. T-scores range from 0 - 100, with a mean of 50 and standard deviation of 10. | Posted | Median | Inter-Quartile Range | T-score on a scale | 1-month |
|
|
|
| Other Pre-specified | Depression | Patient Reported Outcome Measurement Information System (PROMIS) depression short form T-score with higher scores indicating worse outcome. T-scores range from 0-100, with a mean of 50 and standard deviation of 10. | Posted | Median | Inter-Quartile Range | T-score on a scale | 1-month |
|
|
|
| Other Pre-specified | PROMIS Pain Behavior | Patient Reported Outcome Measurement Information System (PROMIS) pain behavior (T-score with mean of 50 and standard deviation of 10) parent report forms; Higher scores indicate worse pain outcomes | Posted | Median | Inter-Quartile Range | T-score on a scale | 1-month |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 4 |
| 10 |
| EG001 | Placebo | Placebo placebo: microcrystalline cellulose filled capsule | 0 | 11 | 0 | 11 | 2 | 11 |
|
| Headaches | Nervous system disorders | Systematic Assessment |
|
| Behavior change with increased anxiety | General disorders | Systematic Assessment |
|
| double vision | Eye disorders | Systematic Assessment |
|
| motion sickness | Ear and labyrinth disorders | Systematic Assessment |
|
| nightmares | Psychiatric disorders | Systematic Assessment |
|
| tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Appetite change | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Sleep/rest Fatigue Subscale |
|
| Cognitive Fatigue Subscale |
|
| Nausea, vomiting at discharge |
|
| headaches at discharge |
|
| None |
|
| Patient wanted to stop medication |
|
| Transitioning between parent houses or moving |
|
| Fell asleep before taking medication |
|
| forgot about sleep education |
|
| Did not see sleep education in paperwork |
|