Improving Infant Hydrocephalus Outcomes in Uganda

Hydrocephalus Clinical Trial

Official title:

Improving Infant Hydrocephalus Outcomes in Uganda: Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure After ETV/CPC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03650101
• Other study ID #: P00029806
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: January 2026

Study information

• Verified date: August 2023
• Source: Boston Children's Hospital
• Contact: Pei-Yi Lin, PhD
• Phone: 6179191308
• Email: Ivy.Lin[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 180 Days

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Procedure:
• ETV/CPC
The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
Uganda	Cure Children's Hospital of Uganda	Mbale
United States	Penn State University	University Park	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Boston Children's Hospital	CURE Children's Hospital, Uganda, The Hospital for Sick Children, Yale University

Countries where clinical trial is conducted

United States,  Canada,  Uganda, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score	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.	24 months of age
Primary	Incidence of ETV/CPC treatment failure	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.	6 months post-treatment
Secondary	Cerebral oxygen metabolism	cerebral oxygen metabolism will be measured with near-infrared spectroscopy	pre- and post-, 6, 12 months post-treatment and 24 months of age
Secondary	brain volume	brain volume will be quantitatively estimated from the head CT scan	pre-, 6, 12 months post-treatment and 24 months of age
Secondary	Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score at 12 months post-treatment	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) score in the general population is 10±3.	12 months post-treatment