Improving Infant Hydrocephalus Outcomes in Uganda: Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure After ETV/CPC
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score
研究概览
简要总结
Neonatal postinfectious hydrocephalus (PIH) is a major public health problem in East Africa.The standard treatment has long been placement of a ventriculoperitoneal shunt (VPS) but these devices require life-long maintenance and nearly all fail multiple times. Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC) is an alternate treatment to give patients a shunt-free life. In this study, the investigators aim to optimize the metrics of evaluation as quantitative prognostic indicators of treatment response and long term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 180 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants less than 180 days (six months) old
- •Symptomatic hydrocephalus characterized by abnormal rate of head growth, full anterior fontanel, ventriculomegaly
- •A parent or a guardian qualified by Ugandan law to give informed consent
- •Patients from Eastern, Central and Northern districts of Uganda, and in geographic proximity to CURE hospital will be eligible
排除标准
- •Age greater than six months
- •No evidence of progressive hydrocephalus
- •Patients outside of the districts specified in the inclusion criteria
研究组 & 干预措施
Hydrocephalus group
Inclusion criteria:
- Age less than six months
- Symptomatic hydrocephalus characterized by abnormal rate of head growth, full anterior fontanel, ventriculomegaly
- A parent or a guardian qualified by Ugandan law to give informed consent
- Patients from Eastern, Central and Northern districts of Uganda, and in geographic proximity to CURE hospital will be eligible
Exclusion criteria:
- Age greater than six months
- No evidence of progressive hydrocephalus
- Patients outside of the districts specified in the inclusion criteria
干预措施: ETV/CPC (Procedure)
Control group
Inclusion criteria:
- Born at GA ≥ 37 weeks
- Age less than six months at the time of enrollment
- No known medical conditions
- With a parent or a guardian qualified by Ugandan law to give informed consent
- Parents live in one of the villages in the Mbale or Budaka District, in geographic proximity to CCHU.
Exclusion criteria:
- Born at GA < 37 weeks
- Age greater than six months
- Evidence of one or more medical conditions
- Living outside of the districts specified in the inclusion criteria.
结局指标
主要结局
Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score
时间窗: 24 months of age
Scores on the BSID-3, which is used to evaluate infants and toddlers 1 to 42 months of age, range from 1 to 19, with higher scores indicating better performance; the mean (±standard deviation(SD)) score in the general population is 10±3.
Incidence of ETV/CPC treatment failure
时间窗: 6 months post-treatment
Treatment failure or success will be determined with the use of clinical and radiographic criteria. * Treatment success will be determined as the shift in the growth of head circumference to a normal rate, as plotted on a standard growth chart; decompression of the anterior fontanel; relief of symptoms of elevated intracranial pressure, such as irritability and vomiting; resolution of down-gaze or sixth cranial nerve palsy; and a decrease or arrest in ventriculomegaly as determined on Computerized Tomography (CT). * Treatment failure will be defined as treatment-related death or the need for a second operation for infection or for the recurrence of hydrocephalus.
次要结局
- brain volume(pre-, 6, 12 months post-treatment and 24 months of age)
- Cerebral oxygen metabolism(pre- and post-, 6, 12 months post-treatment and 24 months of age)
- Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score at 12 months post-treatment(12 months post-treatment)
研究者
Pei-Yi Lin
Assistant Professor
Boston Children's Hospital