A Multi-center and Multidisciplinary Research Project on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Death or the occurrence of neurodevelopmental disorders (NDI) before the corrected gestational age of 2 years.
研究概览
简要总结
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Low-threshold intervention group
VI>P97，but ≤ P97+4mm
干预措施: ommaya capsule implantation technique (Procedure)
high-threshold intervention group
VI>P97+4mm
干预措施: ommaya capsule implantation technique (Procedure)
结局指标
主要结局
Death or the occurrence of neurodevelopmental disorders (NDI) before the corrected gestational age of 2 years.
时间窗: 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.
次要结局
未报告次要终点