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Randomized Controlled Trial Comparative Study
Endoscopic Treatment versus Shunting for Infant Hydrocephalus in Uganda.
- Abhaya V Kulkarni, Steven J Schiff, Edith Mbabazi-Kabachelor, John Mugamba, Peter Ssenyonga, Ruth Donnelly, Jody Levenbach, Vishal Monga, Mallory Peterson, Michael MacDonald, Venkateswararao Cherukuri, and Benjamin C Warf.
- From the University of Toronto (A.V.K.) and the Hospital for Sick Children (A.V.K., R.D., J.L.), Toronto; Pennsylvania State University, University Park (S.J.S., V.M., M.P., M.M., V.C.); CURE Children's Hospital of Uganda, Mbale (E.M.-K., J.M., P.S., B.C.W.); and Harvard Medical School and Boston Children's Hospital, Boston (B.C.W.).
- N. Engl. J. Med. 2017 Dec 21; 377 (25): 2456-2464.
BackgroundPostinfectious hydrocephalus in infants is a major health problem in sub-Saharan Africa. The conventional treatment is ventriculoperitoneal shunting, but surgeons are usually not immediately available to revise shunts when they fail. Endoscopic third ventriculostomy with choroid plexus cauterization (ETV-CPC) is an alternative treatment that is less subject to late failure but is also less likely than shunting to result in a reduction in ventricular size that might facilitate better brain growth and cognitive outcomes.MethodsWe conducted a randomized trial to evaluate cognitive outcomes after ETV-CPC versus ventriculoperitoneal shunting in Ugandan infants with postinfectious hydrocephalus. The primary outcome was the Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score 12 months after surgery (scores range from 1 to 19, with higher scores indicating better performance). The secondary outcomes were BSID-3 motor and language scores, treatment failure (defined as treatment-related death or the need for repeat surgery), and brain volume measured on computed tomography.ResultsA total of 100 infants were enrolled; 51 were randomly assigned to undergo ETV-CPC, and 49 were assigned to undergo ventriculoperitoneal shunting. The median BSID-3 cognitive scores at 12 months did not differ significantly between the treatment groups (a score of 4 for ETV-CPC and 2 for ventriculoperitoneal shunting; Hodges-Lehmann estimated difference, 0; 95% confidence interval [CI], -2 to 0; P=0.35). There was no significant difference between the ETV-CPC group and the ventriculoperitoneal-shunt group in BSID-3 motor or language scores, rates of treatment failure (35% and 24%, respectively; hazard ratio, 0.7; 95% CI, 0.3 to 1.5; P=0.24), or brain volume (z score, -2.4 and -2.1, respectively; estimated difference, 0.3; 95% CI, -0.3 to 1.0; P=0.12).ConclusionsThis single-center study involving Ugandan infants with postinfectious hydrocephalus showed no significant difference between endoscopic ETV-CPC and ventriculoperitoneal shunting with regard to cognitive outcomes at 12 months. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01936272 .).
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