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

Taylor A Vadset, Ajay Rajaram, Chuan-Heng Hsiao, Miriah Kemigisha Katungi, Joshua Magombe, Marvin Seruwu, Brian Kaaya Nsubuga, Rutvi Vyas, Julia Tatz, Katharine Playter, Esther Nalule, Davis Natukwatsa, Moses Wabukoma, Luis E Neri Perez, Ronald Mulondo, Jennifer T Queally, Aaron Fenster, Abhaya V Kulkarni, Steven J Schiff, Patricia Ellen Grant, Edith Mbabazi Kabachelor, Benjamin C Warf, Jason D B Sutin, Pei-Yi Lin, Taylor A Vadset, Ajay Rajaram, Chuan-Heng Hsiao, Miriah Kemigisha Katungi, Joshua Magombe, Marvin Seruwu, Brian Kaaya Nsubuga, Rutvi Vyas, Julia Tatz, Katharine Playter, Esther Nalule, Davis Natukwatsa, Moses Wabukoma, Luis E Neri Perez, Ronald Mulondo, Jennifer T Queally, Aaron Fenster, Abhaya V Kulkarni, Steven J Schiff, Patricia Ellen Grant, Edith Mbabazi Kabachelor, Benjamin C Warf, Jason D B Sutin, Pei-Yi Lin

Abstract

Infant hydrocephalus poses a severe global health burden; 80% of cases occur in the developing world where patients have limited access to neurosurgical care. Surgical treatment combining endoscopic third ventriculostomy and choroid plexus cauterization (ETV/CPC), first practiced at CURE Children's Hospital of Uganda (CCHU), is as effective as standard ventriculoperitoneal shunt (VPS) placement while requiring fewer resources and less post-operative care. Although treatment focuses on controlling ventricle size, this has little association with treatment failure or long-term outcome. This study aims to monitor the progression of hydrocephalus and treatment response, and investigate the association between cerebral physiology, brain growth, and neurodevelopmental outcomes following surgery. We will enroll 300 infants admitted to CCHU for treatment. All patients will receive pre/post-operative measurements of cerebral tissue oxygenation (SO2), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO2) using frequency-domain near-infrared combined with diffuse correlation spectroscopies (FDNIRS-DCS). Infants will also receive brain imaging, to monitor tissue/ventricle volume, and neurodevelopmental assessments until two years of age. This study will provide a foundation for implementing cerebral physiological monitoring to establish evidence-based guidelines for hydrocephalus treatment. This paper outlines the protocol, clinical workflow, data management, and analysis plan of this international, multi-center trial.

Keywords: brain growth; cerebral blood flow; cerebral oxygen metabolism; diffuse correlation spectroscopy; endoscopic third ventriculostomy combined with choroid plexus cauterization; frequency-domain near-infrared spectroscopy; hydrocephalus; neurodevelopmental outcome; tissue saturation.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
(a) Clinical and research workflow, (b) Scheduled patient research follow-ups.
Figure 2
Figure 2
Example of (A) an FDNIRS-DCS study measurement and (B) a baseline neurodevelopmental outcome assessment with a patient.

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