Research on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ommaya capsule implantation technique.
- Who it may be relevant to
- Registry conditions: Intraventricular Hemorrhage of Prematurity. Basic parameters: up to 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center and Multidisciplinary Research Project on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
Overview
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.
Interventions
- Procedure ommaya capsule implantation technique
Intervention criteria: Low-threshold intervention group and high--threshold intervention group
Primary outcome measures
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07157020 · SAHoWMU-CR2025-06-108