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A Study on the Role of Vitamin K2 in Brain Injury Among Preterm Infants via the Microbe-Gut-Brain Axis: A Multicentre Prospective Cohort Study

A Study on the Role of Vitamin K2 in Brain Injury Among Preterm Infants via the Microbe-Gut-Brain Axis: A Multicentre Prospective Cohort Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118433
Enrollment
Unknown
Registered
2026-02-05
Start date
2026-02-10
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Perinatal white matter injury in preterm infants

Interventions

Vitamin K2 Normal Group:None
Vitamin K2 deficiency group:None

Sponsors

Guangzhou Medical University Affiliated Women and Children's Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Preterm infants with a gestational age of less than 37 weeks; Serum vitamin K2 level testing completed within 7 days of birth; Parents sign an informed consent form.

Exclusion criteria

Exclusion criteria: Major congenital malformations or chromosomal abnormalities; severe perinatal complications (such as severe intraventricular haemorrhage); children for whom follow-up is difficult to complete.

Design outcomes

Primary

MeasureTime frame
MRI+DTI/Cranial ultrasound;Faecal Microbiome and Metabolite Analysis;Vitamin K2 concentration;Bayley Scales of Infant Development;Inflammatory mediators;

Countries

China

Contacts

Public ContactHongmei Tang

Guangzhou Medical University Affiliated Women and Children's Medical Centre

gdthm@126.com+86 189 2752 3984

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026