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
Affiliations
Taylor A. Vadset
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
Ajay Rajaram
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
Chuan-Heng Hsiao
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
Miriah Kemigisha Katungi
CURE Children’s Hospital of Uganda, Mbale P.O. Box 903, Uganda
Joshua Magombe
CURE Children’s Hospital of Uganda, Mbale P.O. Box 903, Uganda
Marvin Seruwu
CURE Children’s Hospital of Uganda, Mbale P.O. Box 903, Uganda
Brian Kaaya Nsubuga
CURE Children’s Hospital of Uganda, Mbale P.O. Box 903, Uganda
Rutvi Vyas
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
Julia Tatz
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
Katharine Playter
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
Esther Nalule
CURE Children’s Hospital of Uganda, Mbale P.O. Box 903, Uganda
Davis Natukwatsa
CURE Children’s Hospital of Uganda, Mbale P.O. Box 903, Uganda
Moses Wabukoma
CURE Children’s Hospital of Uganda, Mbale P.O. Box 903, Uganda
Luis E. Neri Perez
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
Ronald Mulondo
CURE Children’s Hospital of Uganda, Mbale P.O. Box 903, Uganda
Jennifer T. Queally
Department of Psychiatry, Boston Children’s Hospital, Harvard Medical School, Boston, MA 02115, USA
Aaron Fenster
Robarts Research Institute, Western University, London, ON N6A 3K7, Canada
Abhaya V. Kulkarni
The Hospital for Sick Children, Toronto, ON M5G 1X8, Canada
Steven J. Schiff
Center for Neural Engineering, Center for Infectious Disease Dynamics, Departments of Engineering Science and Mechanics, Neurosurgery, and Physics, The Pennsylvania State University, University Park, PA 16802, USA
Patricia Ellen Grant
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
Edith Mbabazi Kabachelor
CURE Children’s Hospital of Uganda, Mbale P.O. Box 903, Uganda
Benjamin C. Warf
Department of Neurosurgery, Boston Children’s Hospital, Harvard Medical School, Boston, MA 02115, USA
Jason D. B. Sutin
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
Pei-Yi Lin
Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA 02115, USA
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.
