Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Dec 21;377(25):2456-2464.
doi: 10.1056/NEJMoa1707568.

Endoscopic Treatment versus Shunting for Infant Hydrocephalus in Uganda

Abhaya V Kulkarni #  1 , Steven J Schiff #  1 , Edith Mbabazi-Kabachelor  1 , John Mugamba  1 , Peter Ssenyonga  1 , Ruth Donnelly  1 , Jody Levenbach  1 , Vishal Monga  1 , Mallory Peterson  1 , Michael MacDonald  1 , Venkateswararao Cherukuri  1 , Benjamin C Warf #  1
Affiliations
Randomized Controlled Trial

Endoscopic Treatment versus Shunting for Infant Hydrocephalus in Uganda

Abhaya V Kulkarni et al. N Engl J Med. .

Abstract

Background: Postinfectious 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.

Methods: We 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.

Results: A 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).

Conclusions: This 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 .).

PubMed Disclaimer

Figures

Figure 1
Figure 1
Enrollment, Randomization, Treatment, and Follow-up.
Figure 2
Figure 2. Kaplan–Meier Survival Curves for Time to First Treatment Failure in the Intention-to-Treat Population
ETV–CPC denotes endoscopic third ventriculostomy with choroid plexus cauterization.
Figure 3
Figure 3. Brain Volume
Panels A and B show brain-volume trajectories for female and male patients, determined by examination of preoperative, 6-month postoperative, and 12-month postoperative scans. Curve fits (Weibull distribution) to normative data are indicated with black lines representing the age-adjusted mean and 1 and 2 SD above and below the mean. The scans represented by the circled data points in Panel A are shown in Panels C and D (for a patient in each treatment group who had catch-up growth to the normal range), and the scans represented by circled data points in Panel B are shown in Panels E and F (for a patient in each treatment group who had growth failure). In Panels C through F, the preoperative (baseline) scan is shown on the left, and the corresponding 12-month postoperative scan is shown on the right.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Warf BC. Educate one to save a few, educate a few to save many. World Neurosurg. 2013;79(2 Suppl):S15.e15–S15.e18. - PubMed
    1. Warf BC. Hydrocephalus in Uganda: the predominance of infectious origin and primary management with endoscopic third ventriculostomy. J Neurosurg. 2005;102:1–15. - PubMed
    1. Warf BC, Alkire BC, Bhai S, et al. Costs and benefits of neurosurgical intervention for infant hydrocephalus in sub-Saharan Africa. J Neurosurg Pediatr. 2011;8:509–21. - PubMed
    1. Warf BC. Comparison of 1-year outcomes for the Chhabra and Codman-Hakim Micro Precision shunt systems in Uganda: a prospective study in 195 children. J Neurosurg. 2005;102:358–62. - PubMed
    1. Lane JD, Mugamba J, Ssenyonga P, Warf BC. Effectiveness of the Bactiseal Universal Shunt for reducing shunt infection in a sub-Saharan African context: a retrospective cohort study in 160 Ugandan children. J Neurosurg Pediatr. 2014;13:140–4. - PubMed

Publication types

Associated data