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Research project on prevention, early detection, and clinical evaluation of intracranial hemorrhage in preterm infants

A multi-center and multidisciplinary research project on prevention, early detection, and clinical evaluation of intracranial hemorrhage in preterm infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103386
Enrollment
Unknown
Registered
2025-05-28
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Intraventricular Hemorrhage (IVH) in Preterm Infants?Posthemorrhagic Hydrocephalus (PHH) in Preterm Infants

Interventions

High-Threshold Group:Lumbar Puncture with Cerebrospinal Fluid (CSF) Drainage?Ommaya Reservoir Placement?Ventriculoperitoneal (VP) Shunt Placement
Low-Threshold Group:Lumbar Puncture with Cerebrospinal Fluid (CSF) Drainage?Ommaya Reservoir Placement?Ventriculoperitoneal (VP) Shunt Placement

Sponsors

The Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Study 1 Inclusion Criteria: Infants born at a gestational age of 23-0 to 36-6 weeks, appropriate for gestational age (AGA), with normal neurological development. 2.Study 3 Inclusion Criteria :1.Gestational age ranging from 23+0 to 36+6 weeks Posthemorrhagic hydrocephalus confirmed by cranial ultrasound or other neuroimaging modalities ; 2. No prior history of cerebrospinal fluid diversion interventions before enrollment;3.Before enrollment, the participant has not undergone any cerebrospinal fluid drainage procedures.

Exclusion criteria

Exclusion criteria: 1.Study 1 Exclusion Criteria : 1.Prenatal or postnatal cranial ultrasound abnormalities, including ventriculomegaly, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), or cerebral malformations ; 2.Complex congenital heart disease, chromosomal abnormalities, inborn errors of metabolism, perinatal asphyxia, or central nervous system infections ; 3. Birth weight or head circumference below the 10th percentile, or head circumference above the 90th percentile for gestational age. 2.Study 3 Exclusion Criteria : 1.Secondary IVH caused by underlying pathologies (including but not limited to congenital malformations, vitamin K1 deficiency, or coagulopathies); 2.Hydrocephalus attributable to alternative etiologies (including but not limited to infections, congenital anomalies, or intracranial mass lesions); 3.Receipt of therapeutic interventions prior to PHH diagnosis or suspicion of active CNS infections.

Design outcomes

Primary

MeasureTime frame
Death or occurrence of neurodevelopmental disorders;

Secondary

MeasureTime frame
Whether there is a neurological infection before VP shunt surgery;Whether to perform a V-P shunt surgery for treatment;

Countries

China

Contacts

Public ContactZhenlang Lin

The Second Affiliated Hospital of Wenzhou Medical University

linzhenlang@hotmail.com+86 577 88002798

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026