Improving Infant Hydrocephalus Outcomes in Uganda

Boston Children's Hospital

Status: Enrolling

Conditions: Hydrocephalus

Treatments: Procedure: ETV/CPC

Study type: Observational

Funder types: Other

Identifiers

NCT03650101

P00029806

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 to 180 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Age greater than six months
• No evidence of progressive hydrocephalus
• Patients outside of the districts specified in the inclusion criteria

Trial design

400 participants in 2 patient groups

Hydrocephalus group

Description:

Inclusion criteria: 1. Age less than six months 2. Symptomatic hydrocephalus characterized by abnormal rate of head growth, full anterior fontanel, ventriculomegaly 3. A parent or a guardian qualified by Ugandan law to give informed consent 4. Patients from Eastern, Central and Northern districts of Uganda, and in geographic proximity to CURE hospital will be eligible Exclusion criteria: 1. Age greater than six months 2. No evidence of progressive hydrocephalus 3. Patients outside of the districts specified in the inclusion criteria

Treatment:

Procedure: ETV/CPC

Control group

Description:

Inclusion criteria: 1. Born at GA ≥ 37 weeks 2. Age less than six months at the time of enrollment 3. No known medical conditions 4. With a parent or a guardian qualified by Ugandan law to give informed consent 5. Parents live in one of the villages in the Mbale or Budaka District, in geographic proximity to CCHU. Exclusion criteria: 1. Born at GA \< 37 weeks 2. Age greater than six months 3. Evidence of one or more medical conditions 4. Living outside of the districts specified in the inclusion criteria.