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临床试验/NCT07198360
NCT07198360尚未招募不适用

Incidence, Risk Factors, and Outcomes of Intraventricular Hemorrhage in Preterm Infants Admitted to the NICU

Assiut University0 个研究点目标入组 300 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
主要终点
. To determine the incidence of IVH in preterm infants within the first 7 days of life using cranial ultrasound. . To assess the grade of IVH (Papile classification I-IV) in preterm infants based on cranial US findings.

研究概览

简要总结

To determine the incidence and grading of IVH among preterm neonates in the NICU.

  • To identify maternal and neonatal risk factors associated with IVH.
  • To assess short-term outcomes (mortality, Hydrocephalus, need for neurosurgical intervention, seizures, length of Hospital stay).

详细描述

Intraventricular hemorrhage (IVH) is described as bleeding that occurs within and surrounding the brain ventricles, which contain cerebrospinal fluid . IVH is one of the most severe complications affecting preterm newborns globally, frequently leading to poor prognoses and potential mortality due to both short- and long-term neurodevelopmental consequences. The risk is markedly elevated for preterm newborns with a short gestational age, as roughly 15-20% of those born prior to 32 weeks of gestation are at the greatest risk of suffering a severe form of intraventricular hemorrhage . In term newborns, IVH occurs with an incidence of 5.5%, primarily due to perinatal head trauma, birth hypoxia, or coagulation disorders .

The IVH is diagnosed using cranial ultrasound (CUS), which is performed within the first 72 hours of life and repeated as clinically indicated. The IVH grade will be classified according to the Papile classification, which includes Grades I, II, III, and IV . Grades I and II were classified as mild intraventricular hemorrhage (IVH), whereas grades III and IV were classified as severe IVH. Grade IV IVH is now designated as periventricular hemorrhage infarction or parenchymal hemorrhage in recent years .

The risk factors for IVH include acute placental inflammation, elevated leukocyte count within the first 72 hours post-birth, increased white blood cell levels, and male sex. Additional risk factors for IVH encompass prematurity, low birthweight (LBW), prolonged mechanical ventilation, a low 5-minute Apgar score, hypoxia-related injury, hypothermic ischemia, pneumothorax, thrombocytopenia, antenatal maternal hemorrhage, maternal infection or inflammation, sepsis, hypotension, hypoxia, hypercapnia, seizures, patent ductus arteriosus (PDA), infection, respiratory distress, and genetic predispositions .

IVH in neonates, particularly preterm infants, often presents with nonspecific clinical signs such as apnea, bradycardia, hypotonia, bulging fontanelle, seizures, or a sudden drop in hematocrit. Some cases may be clinically silent, making routine screening essential . The diagnosis is primarily made using transcranial ultrasound (cranial sonography), which is a non-invasive, bedside imaging tool capable of detecting IVH grades, ventricular dilation, and parenchymal involvement through the anterior fontanelle. Outcomes vary depending on the severity (graded IIV), with lower grades (III) often resolving without long-term consequences, while higher grades (IIIIV) are associated with complications such as post-hemorrhagic hydrocephalus, cerebral palsy, developmental delay, and increased mortality. Early detection through serial ultrasound monitoring plays a critical role in management and prognosis .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm neonates < 34 weeks of gestation
  • Birth weight < 1500g
  • Admitted to NICU within 24 hours of birth

排除标准

  • Major congenital malformations (especially CNS anomalies)
  • Severe perinatal asphyxia
  • Neonates with congenital infections (TORCH)

结局指标

主要结局

. To determine the incidence of IVH in preterm infants within the first 7 days of life using cranial ultrasound. . To assess the grade of IVH (Papile classification I-IV) in preterm infants based on cranial US findings.

时间窗: Baseline

Outcome of intraventricular haemorrhage in preterm infants

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Romany Nady Isaac Ayad

Pediatric resident

Assiut University

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