Research on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-12-31

Brief Summary

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1. Establish a reference curve for the lateral ventricular diameter of premature infants and determine the intervention threshold for hydrocephalus after hemorrhage in premature infants based on the reference curve, providing a scientific basis for optimizing clinical intervention.
2. Apply ultrasound radiomics technology to explore and formulate new standards for imaging diagnosis and treatment; By integrating metabolomics, ultrasound radiomics and clinical data, high-risk individuals for intracranial hemorrhage and their relationship with prognosis can be identified early.
3. To explore whether advancing the indication for surgical intervention of hydrocephalus in preterm infants after hemorrhage from ventricular index P97+4mm to P97 and whether repeated lumbar puncture and drainage can improve their prognosis, with the aim of clarifying the optimal timing for intervention of hydrocephalus in preterm infants after hemorrhage and optimizing the treatment methods.

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Detailed Description

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Conditions

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Intraventricular Hemorrhage of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low-threshold intervention group

VI\>P97，but ≤ P97+4mm

Group Type EXPERIMENTAL

ommaya capsule implantation technique

Intervention Type PROCEDURE

Intervention criteria: Low-threshold intervention group and high--threshold intervention group

high-threshold intervention group

VI\>P97+4mm

Group Type EXPERIMENTAL

ommaya capsule implantation technique

Intervention Type PROCEDURE

Intervention criteria: Low-threshold intervention group and high--threshold intervention group

Interventions

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ommaya capsule implantation technique

Intervention criteria: Low-threshold intervention group and high--threshold intervention group

Intervention Type PROCEDURE

Other Intervention Names

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Lumbar puncture drainage

Eligibility Criteria

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Inclusion Criteria

* Gestational age: 23+0 weeks to 36+6 weeks;
* Post-hemorrhagic hydrocephalus is confirmed by cranial ultrasound or other cranial imaging examinations.
* No cerebrospinal fluid drainage treatment was received before enrollment.

Exclusion Criteria

* Excluding secondary IVH, including but not limited to congenital malformations, vitamin K1 deficiency, abnormal coagulation function, etc.
* Excluding hydrocephalus caused by other reasons, including but not limited to infection, congenital malformations, intracranial space-occupying lesions, etc.
* Treatment before diagnosis of hydrocephalus after intraventricular hemorrhage or suspected presence of central nervous system infection.

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes