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Hormone Therapy

Melatonin for Pediatric Traumatic Brain Injury (SMARTKids Trial)

Q: Am I qualified to participate in this scientific experiment?

This medical trial requires its participants to be suffering from a severe illness and aged between 6 and 18. The total capacity of this experiment is 110 individuals.

Q: Can individuals expect any unwanted side effects from a sleep management regimen?

The risk associated with the <a href="https://www.withpower.com/clinical-trials/sleep">sleep</a> management plan is estimated to be a 2 according to our team at Power. This Phase 2 trial has some evidence in favour of safety, but no data demonstrating efficacy yet.

Q: Is there room for more participants in this experiment?

According to clinicaltrials.gov, this research project is not taking on any new patients at present; the study was initially posted on September 1st 2022 and recently updated on August 11th 2022. Despite this, there are 1198 other studies currently recruiting participants.

Q: What objectives is this scientific experiment seeking to accomplish?

During this 6-month medical trial, the principal objective is to evaluate retention. Other desirable outcomes encompass assessment of adverse events both at baseline and follow-up, as well as fatigue scores obtained via a parent proxy report using the PedsQL Multidimensional Fatigue Scale with 0 representing no function and 100 indicating optimal functioning.

Q: Does this experiment accept elderly participants?

The age criteria for this clinical trial necessitates that participants are between 6 and 18 years old. There is an abundance of trials devoted to children, with 204 studies targeting those below the age of 18, as well as a plethora of 929 research initiatives for seniors above 65.

Phase 2

Recruiting

Led By Cydni Williams, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children age ≥6 years and <19 years

Traumatic brain injury defined as disruption of the normal function of the brain resulting from blunt force injury with a severity defined as mild complicated, moderate, or severe by the Glasgow Coma Scale with the presence of intracranial injury on imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6-months

Awards & highlights

SMARTKids Trial Summary

This trial will test if a melatonin intervention can help reduce sleep wake disturbances for pediatric TBI survivors, which will be measured by questionnaires and activity monitors.

Who is the study for?

This trial is for children aged 6 to <19 years with traumatic brain injury, who are expected to survive their hospital stay at Oregon Health & Science University Hospitals. They must be able to take medications orally within 72 hours of admission and live with a parent or guardian. Excluded are pregnant individuals, prisoners, those without stable communication means, if there's safety concerns about the intervention by the clinical team, suspected abuse cases, patients on dialysis or ECMO, or significant liver injury.Check my eligibility

What is being tested?

The study tests whether melatonin can help kids recover better from traumatic brain injuries by improving sleep after they leave the hospital. It compares melatonin treatment started in the hospital and continued at home against a placebo (a dummy pill). The effectiveness will be measured using sleep scales and activity monitors one month post-discharge.See study design

What are the potential side effects?

While not explicitly listed in your information provided, common side effects of melatonin may include drowsiness during daytime, headache and dizziness. As this is a controlled trial involving children recovering from TBI, close monitoring will likely identify any additional side effects.

SMARTKids Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 6 and 18 years old.

Select...

I have had a brain injury from a blow to the head, confirmed by brain scans.

SMARTKids Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recruitment

Retention

sleep disturbance

Secondary outcome measures

Chronotype

Fatigue

adherence qualitative

+10 more

Other outcome measures

anxiety

cognitive functioning

depression

+4 more

Side effects data

From 2017 Phase 3 trial • 709 Patients • NCT00668707

16%

Fatgiue

11%

Insomnia

10%

Death

Nausea

Dyspnea

Diarrhea

Postoperative Pain

Constipation

Cough

Vomiting

Headache

Peripheral Neuropathy

Neutropenia

Appetite changes

Air Leak

Dizziness

Chest pain

Cold/Flu Symptoms

Weight loss

Pneumothorax

New Neoplasm - Lung Cancer

dry mouth

Anorexia

Anemia

Pneumonia

Back pain

Erythema

Flatulence

Vertigo

Bonchitis

Pulmonary embolism

Gall bladder attack

GERD

Anxiety

Tinnitus

Depression

Syncope

Acid reflux

Epistaxis

Pruritis

Rash

Prolonged Air Leak

Hyperglycemia

Thrush (mouth)

Hip replacement surgery

Subcutaneous Emphysema

Atrial fibrillation

Indigestion

Peripheral Edema

C-Difficile

Surgical site infection

Fall

Pain

Radiation pneumonitis

Surgical Site Pain

Dry Cough

Pleural effusion

New Neoplasm

Hypertension

Tachycardia

Dysphagia

Sinus infection

Myalgia

Hearing loss

Hemoptysis

100%

80%

60%

40%

20%

Study treatment Arm

Melatonin

Placebo

SMARTKids Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MelatoninExperimental Treatment1 Intervention

(melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days)

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

melatonin

2013

Completed Phase 3

~2260

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,882 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,094 Total Patients Enrolled

Cydni Williams, MDPrincipal InvestigatorOregon Health and Science University

Media Library

Melatonin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04932096 — Phase 2

Traumatic Brain Injury Research Study Groups: Melatonin, Placebo

Traumatic Brain Injury Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT04932096 — Phase 2

Melatonin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04932096 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to participate in this scientific experiment?

"This medical trial requires its participants to be suffering from a severe illness and aged between 6 and 18. The total capacity of this experiment is 110 individuals."

Answered by AI

Can individuals expect any unwanted side effects from a sleep management regimen?

"The risk associated with the sleep management plan is estimated to be a 2 according to our team at Power. This Phase 2 trial has some evidence in favour of safety, but no data demonstrating efficacy yet."

Answered by AI

Is there room for more participants in this experiment?

"According to clinicaltrials.gov, this research project is not taking on any new patients at present; the study was initially posted on September 1st 2022 and recently updated on August 11th 2022. Despite this, there are 1198 other studies currently recruiting participants."

Answered by AI

What objectives is this scientific experiment seeking to accomplish?

"During this 6-month medical trial, the principal objective is to evaluate retention. Other desirable outcomes encompass assessment of adverse events both at baseline and follow-up, as well as fatigue scores obtained via a parent proxy report using the PedsQL Multidimensional Fatigue Scale with 0 representing no function and 100 indicating optimal functioning."

Answered by AI

Does this experiment accept elderly participants?

"The age criteria for this clinical trial necessitates that participants are between 6 and 18 years old. There is an abundance of trials devoted to children, with 204 studies targeting those below the age of 18, as well as a plethora of 929 research initiatives for seniors above 65."

Answered by AI

Recent research and studies

Pediatric NeurologyJournal

Sleep-wake Disturbances After Acquired Brain Injury in Children Surviving Critical Care

Williams, Cydni N., Mary E. Hartman, Cindy T. McEvoy, Trevor A. Hall, Miranda M. Lim, Steven A. Shea, Madison Luther, et al.. 2020. “Sleep-wake Disturbances After Acquired Brain Injury in Children Surviving Critical Care”. Pediatric Neurology. Elsevier BV. doi:10.1016/j.pediatrneurol.2019.08.010.

SleepJournal

Sleep Disturbances After Pediatric Traumatic Brain Injury: A Systematic Review of Prevalence, Risk Factors, and Association with Recovery

Luther, Madison, Katrina M Poppert Cordts, and Cydni N Williams. 2020. “Sleep Disturbances After Pediatric Traumatic Brain Injury: A Systematic Review of Prevalence, Risk Factors, and Association with Recovery”. Sleep. Oxford University Press (OUP). doi:10.1093/sleep/zsaa083.

Neurocritical CareJournal

Sleep Measure Validation in a Pediatric Neurocritical Care Acquired Brain Injury Population

Poppert Cordts, Katrina M., Trevor A. Hall, Mary E. Hartman, Madison Luther, Amanda Wagner, Juan Piantino, Kristin P. Guilliams, Rejean M. Guerriero, Jalane Jara, and Cydni N. Williams. 2019. “Sleep Measure Validation in a Pediatric Neurocritical Care Acquired Brain Injury Population”. Neurocritical Care. Springer Science and Business Media LLC. doi:10.1007/s12028-019-00883-5.

clinicaltrials.govStudy