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Exploring the role and mechanism of melatonin in treating pediatric traumatic brain injury based on the BNIP3-mediated mitophagy pathway

Exploring the role and mechanism of melatonin in treating pediatric traumatic brain injury based on the BNIP3-mediated mitophagy pathway

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123944
Enrollment
Unknown
Registered
2026-05-03
Start date
2026-05-04
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury

Interventions

Control group (moderate to severe TBI):Children with moderate to severe TBI received treatments such as monitoring, control of intracranial pressure, analgesia and sedation, and surgery when necessary
MLT group (moderate to severe TBI):Children with moderate to severe TBI received MLT orally or via nasogastric tube (1–2 mg per dose, once daily) for one week in addition to conventional treatment.
Mild TBI group:Without any intervention, only the serum melatonin expression levels of the pediatric patients were detected.

Sponsors

Xuzhou Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Has a clear history of brain trauma, confirmed by head CT scan or magnetic resonance imaging (MRI); 2. Age 2-18 years old; 3. Glasgow Coma Scale (GCS) <= 12 points; 4. Time from injury to admission < 24 hours; 5. No previous neurological diseases or brain trauma; 6. No other severe organic lesions in other organs; 7. Parental informed consent of the child is obtained.

Exclusion criteria

Exclusion criteria: 1. Combined central nervous system infection; 2. Need for fasting due to digestive system diseases or trauma; 3. Having underlying diseases such as autoimmune diseases, blood diseases, endocrine diseases or malignant tumors; 4. Parents refuse to participate or withdraw from the study halfway.

Design outcomes

Primary

MeasureTime frame
Glasgow Coma Scale;GOS Prognostic Score;Melatonin;

Secondary

MeasureTime frame
Neuron-specific enolase;S100B Protein;Glial Fibrillary Acidic Protein;Ubiquitin C-Terminal Hydrolase L1;Malondialdehyde;Superoxide Dismutase;8-iso-Prostaglandin;Tumor Necrosis Factor-alpha;Interleukin-6;Interleukin-1 beta;Brain-Derived Neurotrophic Factor;

Countries

China

Contacts

Public ContactZhu Lei

Xuzhou Children's Hospital

xuzhouzhulei317@163.com+86 136 8513 4366

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026