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NCT Number: NCT07157020

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

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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Key information

Conditions

Intraventricular Hemorrhage of Prematurity

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ommaya capsule implantation technique

Procedure

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

Other names: Lumbar puncture drainage

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

A Multi-center and Multidisciplinary Research Project on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants

Acronym: ROPEDACEOIHIPI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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