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

NCT07157020 | Not Yet Recruiting DMC

• 1 other identifier: SAHoWMU-CR2025-06-108
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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. 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.

Conditions

Intraventricular Hemorrhage of Prematurity

Keywords

Intraventricular Hemorrhage of Prematurity; prevention; early detection; clinical evaluation

Outcome Measures

Primary Outcomes (1)

• Death or the occurrence of neurodevelopmental disorders (NDI) before the corrected gestational age of 2 years.

  NDI can be diagnosed if any of the following conditions are met. * Cerebral palsy; * Griffiths score \<85 points for the corresponding age: The assessment times are CA at 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months respectively. Any assessment score lower than 85 points is considered a positive event. * Sensorineural or mixed hearing impairment and non-congenital hearing loss require hearing AIDS or cochlear implants ④ Bilateral visual impairment; * Epilepsy.

  The assessment times are CA at 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months respectively.

Study Arms (2)

Low-threshold intervention group

EXPERIMENTAL

VI\>P97，but ≤ P97+4mm

Procedure: ommaya capsule implantation technique

high-threshold intervention group

EXPERIMENTAL

VI\>P97+4mm

Procedure: ommaya capsule implantation technique

Interventions

ommaya capsule implantation technique PROCEDURE

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

Also known as: Lumbar puncture drainage

Low-threshold intervention group; high-threshold intervention group

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share