Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin (SMARTKids)

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2

Conditions: Traumatic Brain Injury; Critical Illness; Sleep

Treatments: Drug: melatonin; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04932096

1K23HL150229-01A1 (U.S. NIH Grant/Contract)

GPEDI1282A

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• 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
• Admission to Oregon Health & Science University Hospitals
• Deemed likely to survive hospitalization by clinical care team
• Able to tolerate enteral medications within 72 hours of admission
• Child participant resides with parent or legal guardian

Exclusion:

• Lack stable means of communication with study team (phone, email, mailing address)
• Abusive trauma suspected or confirmed
• Dialysis
• Extracorporeal support (e.g. ECMO)
• Significant liver injury defined as >2x normal levels for AST or ALT
• Clinical team safety concerns with use of intervention
• Pregnancy
• Prisoners

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

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

Treatment:

Drug: melatonin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: placebo