Clinical trial NCT03650101: Improving Infant Hydrocephalus Outcomes in Uganda
Official title: Improving Infant Hydrocephalus Outcomes in Uganda: Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure After ETV/CPC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hydrocephalus
Keywords: Hydrocephalus
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: CURE Children's Hospital, Uganda
name: Yale University
First posted: 2018-08-28
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants less than six months old with progressive hydrocephalus

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score
timeFrame: 24 months of age
measure: Incidence of ETV/CPC treatment failure
timeFrame: 6 months post-treatment
Secondary outcomes:
measure: Cerebral oxygen metabolism
timeFrame: pre- and post-, 6, 12 months post-treatment and 24 months of age
measure: brain volume
timeFrame: pre-, 6, 12 months post-treatment and 24 months of age
measure: Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score at 12 months post-treatment
timeFrame: 12 months post-treatment
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Mbale
country: Uganda
facility: Cure Children's Hospital of Uganda
Study officials:
affiliation: Boston Children's Hospital
name: Pei-Yi Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vadset TA, Rajaram A, Hsiao CH, Kemigisha Katungi M, Magombe J, Seruwu M, Kaaya Nsubuga B, Vyas R, Tatz J, Playter K, Nalule E, Natukwatsa D, Wabukoma M, Neri Perez LE, Mulondo R, Queally JT, Fenster A, Kulkarni AV, Schiff SJ, Grant PE, Mbabazi Kabachelor E, Warf BC, Sutin JDB, Lin PY. Improving Infant Hydrocephalus Outcomes in Uganda: A Longitudinal Prospective Study Protocol for Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure after ETV/CPC. Metabolites. 2022 Jan 14;12(1):78. doi: 10.3390/metabo12010078.