Trial Outcomes & Findings for Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin (NCT NCT04932096)
NCT ID: NCT04932096
Last Updated: 2025-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
1-month
Results posted on
2025-08-20
Participant Flow
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.
Participant milestones
| Measure |
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
|
Placebo
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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
|
Placebo
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Partial completion (did not complete primary outcome survey)
|
0
|
1
|
Baseline Characteristics
Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
Baseline characteristics by cohort
| Measure |
Melatonin
n=10 Participants
(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
|
Placebo
n=11 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.3 years
n=5 Participants
|
12.8 years
n=7 Participants
|
10.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Medicaid Insurance Status
Medicaid
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Medicaid Insurance Status
Private Insurance
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Admission Glasgow Coma Scale Score
Mild, score 13-15
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Admission Glasgow Coma Scale Score
Moderate, score 9-12
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Admission Glasgow Coma Scale Score
Severe, score 3-8
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Pre-injury medical condition present
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Pre-injury psychological diagnosis present
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Pre-injury neurodevelopmental condition present
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Skull fracture present at admission
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Intracranial injury on imaging present at admission
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Other injuries (non-brain) present at admission
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Inpatient Rehabilitation Discharge Disposition
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sleep Disturbances Scale for Children Total score
|
60 T-score
n=5 Participants
|
63 T-score
n=7 Participants
|
60 T-score
n=5 Participants
|
|
Sleep Disturbances Scale for Children Initiation and Maintenance Subscale
|
64 T-score
n=5 Participants
|
76 T-score
n=7 Participants
|
66 T-score
n=5 Participants
|
|
Sleep Disturbances Scale for Children Breathing Subscale
|
51 T-score
n=5 Participants
|
51 T-score
n=7 Participants
|
51 T-score
n=5 Participants
|
|
Sleep Disturbances Scale for Children Arousal Subscale
|
47 T-score
n=5 Participants
|
47 T-score
n=7 Participants
|
47 T-score
n=5 Participants
|
|
Sleep Disturbances Scale for Children Sleep Wake Transition Subscale
|
62 T-score
n=5 Participants
|
50 T-score
n=7 Participants
|
54 T-score
n=5 Participants
|
|
Sleep Disturbances Scale for Children Somnolence Subscale
|
50 T-score
n=5 Participants
|
50 T-score
n=7 Participants
|
50 T-score
n=5 Participants
|
|
Sleep Disturbances Scale for Children Hyperhidrosis Subscale
|
45 T-score
n=5 Participants
|
45 T-score
n=7 Participants
|
45 T-score
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-monthSleep 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.
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Sleep Disturbances Scale for Children
Total T-score
|
55 T-score
Interval 47.0 to 68.0
|
69 T-score
Interval 63.0 to 79.0
|
|
Sleep Disturbances Scale for Children
Initiation and Maintenance T-score
|
64 T-score
Interval 50.0 to 89.0
|
73 T-score
Interval 64.0 to 79.0
|
|
Sleep Disturbances Scale for Children
Breathing T-score
|
51 T-score
Interval 45.0 to 51.0
|
58 T-score
Interval 51.0 to 58.0
|
|
Sleep Disturbances Scale for Children
Arousal T-score
|
47 T-score
Interval 47.0 to 47.0
|
58 T-score
Interval 47.0 to 58.0
|
|
Sleep Disturbances Scale for Children
Transition T-score
|
50 T-score
Interval 50.0 to 54.0
|
54 T-score
Interval 50.0 to 79.0
|
|
Sleep Disturbances Scale for Children
Somnolence T-score
|
50 T-score
Interval 50.0 to 50.0
|
62 T-score
Interval 53.0 to 73.0
|
|
Sleep Disturbances Scale for Children
Hyperhidrosis T-Score
|
45 T-score
Interval 45.0 to 51.0
|
45 T-score
Interval 45.0 to 45.0
|
PRIMARY outcome
Timeframe: through study completion, an average of 6-monthsPopulation: Number of eligible patients approached for consent
Quantitative number of patients consented per patients approached
Outcome measures
| Measure |
Melatonin
n=53 Participants
(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
|
Placebo
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Recruitment
|
21 Participants
|
—
|
PRIMARY outcome
Timeframe: through study completion, an average of 30 daysQuantitative number of participants completing trial procedures per patients consented
Outcome measures
| Measure |
Melatonin
n=21 Participants
(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
|
Placebo
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Retention
Completion of Sleep Disturbances Scale for Children Survey
|
18 Participants
|
—
|
|
Retention
Completion of other procedures but not Sleep Disturbances Scale for Children survey
|
1 Participants
|
—
|
|
Retention
Participant withdrawal from study
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 1-monthpill counts, report of using study medication at least 5/7 days per week
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Adherence Quantitative
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 1-monthparticipant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Adherence Qualitative
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 1-monthPediatric 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.
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
Total Score
|
63.9 score on a scale
Interval 58.3 to 83.3
|
54.9 score on a scale
Interval 43.8 to 76.4
|
|
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
General Fatigue Subscale
|
70.8 score on a scale
Interval 62.5 to 79.2
|
50 score on a scale
Interval 37.5 to 87.5
|
|
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
Sleep/rest Fatigue Subscale
|
70.8 score on a scale
Interval 50.0 to 83.3
|
58.3 score on a scale
Interval 33.3 to 85.4
|
|
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
Cognitive Fatigue Subscale
|
75 score on a scale
Interval 63.0 to 79.2
|
54.1 score on a scale
Interval 47.9 to 77.1
|
SECONDARY outcome
Timeframe: 1-monthChildren's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Morningness/Eveningness Scale Score summed from responses, range 10 (morningness) to 49 (eveningness)
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Chronotype
|
24.5 score on a scale
Interval 22.0 to 26.5
|
25 score on a scale
Interval 21.0 to 28.0
|
SECONDARY outcome
Timeframe: 1-monthPopulation: Actigraphy usable providing 5/7 days per week of data
actigraphy measured time in minutes to fall asleep
Outcome measures
| Measure |
Melatonin
n=7 Participants
(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
|
Placebo
n=8 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Sleep Latency
|
4.6 minutes
Interval 3.9 to 7.2
|
5.3 minutes
Interval 2.7 to 12.4
|
SECONDARY outcome
Timeframe: 1-monthPopulation: Actigraphy usable data if 5/7 days per week
actigraphy measured total time asleep in minutes
Outcome measures
| Measure |
Melatonin
n=7 Participants
(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
|
Placebo
n=8 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Total Sleep Time
|
471 minutes
Interval 446.0 to 475.0
|
459 minutes
Interval 413.0 to 496.0
|
SECONDARY outcome
Timeframe: 1-monthactigraphy measured time in minutes awake after sleep onset
Outcome measures
| Measure |
Melatonin
n=7 Participants
(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
|
Placebo
n=8 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Wake After Sleep Onset
|
4.4 minutes
Interval 4.2 to 4.5
|
4.2 minutes
Interval 3.0 to 4.9
|
SECONDARY outcome
Timeframe: 1-monthactigraphy measured number of instances awoken after sleep onset
Outcome measures
| Measure |
Melatonin
n=7 Participants
(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
|
Placebo
n=8 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Number of Night Awakenings
|
31.2 number of awakenings
Interval 28.9 to 34.5
|
30.5 number of awakenings
Interval 26.9 to 32.4
|
SECONDARY outcome
Timeframe: 1-monthactigraphy measure percentage of nighttime period spent asleep
Outcome measures
| Measure |
Melatonin
n=7 Participants
(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
|
Placebo
n=8 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Sleep Efficiency
|
88 percentage of time in bed deemed asleep
Interval 87.3 to 88.1
|
88 percentage of time in bed deemed asleep
Interval 87.2 to 88.4
|
SECONDARY outcome
Timeframe: 1-monthtime 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)
Outcome measures
| Measure |
Melatonin
n=7 Participants
(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
|
Placebo
n=8 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Sleep Onset Time
|
23.42 hours corresponding to time of day
Interval 23.13 to 23.42
|
22.77 hours corresponding to time of day
Interval 22.28 to 23.78
|
SECONDARY outcome
Timeframe: 1-monthtime 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)
Outcome measures
| Measure |
Melatonin
n=7 Participants
(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
|
Placebo
n=8 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Sleep Offset Time
|
8.28 hours corresponding to time of day
Interval 7.97 to 8.52
|
7.58 hours corresponding to time of day
Interval 6.45 to 7.83
|
SECONDARY outcome
Timeframe: hospital discharge assessed up to 7 daysEvaluation 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
Outcome measures
| Measure |
Melatonin
n=10 Participants
(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
|
Placebo
n=11 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Adverse Events Time 0
Readmission to hospital, not study related
|
1 Participants
|
0 Participants
|
|
Adverse Events Time 0
EVD placement and hyponatremia, not study related
|
1 Participants
|
0 Participants
|
|
Adverse Events Time 0
Nausea, vomiting at discharge
|
0 Participants
|
1 Participants
|
|
Adverse Events Time 0
headaches at discharge
|
0 Participants
|
1 Participants
|
|
Adverse Events Time 0
None
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1-monthEvaluation of adverse events asking participants to report any side effects of study interventions
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-monthPopulation: Reasons given for not using study medication every night or sleep plan resources at any frequency
qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan
Outcome measures
| Measure |
Melatonin
n=7 Participants
(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
|
Placebo
n=8 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Reason for Non-adherence
Misplaced medication
|
1 Participants
|
0 Participants
|
|
Reason for Non-adherence
Pharmacy issues
|
0 Participants
|
1 Participants
|
|
Reason for Non-adherence
Patient wanted to stop medication
|
0 Participants
|
1 Participants
|
|
Reason for Non-adherence
Transitioning between parent houses or moving
|
1 Participants
|
1 Participants
|
|
Reason for Non-adherence
Fell asleep before taking medication
|
1 Participants
|
1 Participants
|
|
Reason for Non-adherence
forgot about sleep education
|
2 Participants
|
2 Participants
|
|
Reason for Non-adherence
Did not see sleep education in paperwork
|
2 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-monthPediatric Quality of Life Inventory (PedsQL): parent reported measure of quality of life. Scores range 0-100 with higher scores indicating better quality of life.
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Health Related Quality of Life
|
71.7 score on a scale
Interval 63.0 to 73.2
|
59.8 score on a scale
Interval 48.9 to 79.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-monthBehavior 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.
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Cognitive Functioning
|
52 T-score on a scale
Interval 45.0 to 59.0
|
55 T-score on a scale
Interval 46.0 to 60.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-monthFunctional Status Scale, range 6-30, with higher scores indicating worse function; measured at followup
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Physical Functioning
|
6 score on a scale
Interval 6.0 to 6.0
|
6 score on a scale
Interval 6.0 to 6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-monthPatient 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.
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Anxiety
|
38 T-score on a scale
Interval 34.0 to 45.0
|
50 T-score on a scale
Interval 41.0 to 55.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-monthPatient 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.
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Depression
|
45 T-score on a scale
Interval 36.0 to 57.0
|
47 T-score on a scale
Interval 39.0 to 51.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-monthPatient 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
Outcome measures
| Measure |
Melatonin
n=9 Participants
(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
|
Placebo
n=9 Participants
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
PROMIS Pain Behavior
|
47 T-score on a scale
Interval 42.0 to 51.0
|
10 T-score on a scale
Interval 10.0 to 36.0
|
Adverse Events
Melatonin
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Melatonin
n=10 participants at risk
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
|
Placebo
n=11 participants at risk
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
Nervous system disorders
Readmission to hospital
|
10.0%
1/10 • Number of events 1 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
0.00%
0/11 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
Other adverse events
| Measure |
Melatonin
n=10 participants at risk
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
|
Placebo
n=11 participants at risk
Placebo
placebo: microcrystalline cellulose filled capsule
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/10 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
9.1%
1/11 • Number of events 1 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
|
Nervous system disorders
Headaches
|
20.0%
2/10 • Number of events 2 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
18.2%
2/11 • Number of events 2 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
|
General disorders
Behavior change with increased anxiety
|
0.00%
0/10 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
18.2%
2/11 • Number of events 2 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
|
Eye disorders
double vision
|
10.0%
1/10 • Number of events 1 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
0.00%
0/11 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
|
Ear and labyrinth disorders
motion sickness
|
10.0%
1/10 • Number of events 1 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
0.00%
0/11 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
|
Psychiatric disorders
nightmares
|
10.0%
1/10 • Number of events 1 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
0.00%
0/11 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
|
Ear and labyrinth disorders
tinnitus
|
10.0%
1/10 • Number of events 1 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
0.00%
0/11 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
|
Skin and subcutaneous tissue disorders
itching
|
10.0%
1/10 • Number of events 1 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
0.00%
0/11 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
|
Gastrointestinal disorders
Appetite change
|
10.0%
1/10 • Number of events 1 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
0.00%
0/11 • 30 days and up to 47 days after study start to complete survey
Symptom checklist assessed at follow up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place