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Abstract
Rotavirus (RV) is the most common etiological agent causing acute gastroenteritis (GE) in children aged <5 years. This cross-sectional, hospital-based surveillance study (NCT01201252) was designed to investigate RVGE disease burden. It was conducted from July 2009–July 2010 at 3 referral hospitals in the United Arab Emirates (UAE). Children who had been hospitalized for acute GE were enrolled with informed consent. Stool samples were tested for RV using enzyme immunoassay and RV-positive samples were further typed using reverse transcriptase-polymerase chain reaction and reverse hybridization to determine the G and P types. GE data were collected from medical charts and GE severity was assessed through clinical examination. Treatment and outcome were prospectively recorded. Among 6323 children hospitalized due to any reason, 771 (12.2%) presented acute GE and were enrolled, of whom 758 (98.3%) were included in the final analysis. Acute GE and RVGE accounted for 12.0% (758/6323) and 6.0% (381/6323) of all hospitalizations, respectively. RVGE accounted for 50.3% (381/758) of GE hospitalizations and predominantly affected, children younger than 2 years (66.1%; 252/381). The severity of GE before hospitalization was significantly associated with RV-positive status (P = 0.0031). The majority (>95%) of children received intravenous hydration during hospitalization. RVGE occurred throughout the year, with a subtle winter peak in February 2010 (63.6%; 56/88). G1WTP[8]WT was the most commonly detected RV strain (56.3%) in 268 analyzed samples. RV was a major cause of GE-hospitalizations in children under 5 years in the UAE; the highest number of RVGE cases was observed in children younger than 2 years.
Disclosure of Potential Conflicts of Interest
K.G. and R.D. are both employed by the GlaxoSmithKline group of companies. R.D. declares to have stock options. L.J.V.D. is employed by and is shareholder of DDL Diagnostic Laboratory, which received a fee from GlaxoSmithKline Biologicals for rotavirus genotyping and MH’s institution, received a grant for conducting the study. M.H., G.B. and H.Y. have no competing interests to declare.
Acknowledgments
The authors thank Devi Priya and Shruti Bapna (GlaxoSmithKline Vaccines) for medical writing, Abdelilah Ibrahimi (XPE Pharma and Science on behalf of GlaxoSmithKline Vaccines) for publication coordination, and Julia Donnelly (freelance publication manager on behalf of GlaxoSmithKline Vaccines) for support in copy editing. The authors would also like to acknowledge Dr Ahmad Khalafalla and Runa Mithani for the coordination and monitoring of the study sites (both employed by GlaxoSmithKline group of companies).
Financial Disclosure
GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analyses. GlaxoSmithKline Biologicals SA also paid all costs associated with the development and the publication of the present manuscript.
Trademark Statement
Rotarix is a trademark of the GlaxoSmithKline group of companies
Rotateq is a registered trademark of Merck and Co. Inc.
Rotaclone is a registered trademark of Meridian Bioscience, USA.
Ethical Statements
The trial was registered with clinicaltrials.gov (identifier NCT01201252) and was conducted in accordance with the International Conference on Harmonization Guideline for Good Clinical Practice which has its origins in the Declaration of Helsinki. All participants provided written and informed consent.
Author Contributions
M.H. and G.B. were the coordinating investigators and together with H.Y. were responsible for the conduct of the study. K.G. contributed to the study design and performed the statistical analysis. L.J.V.D. was responsible for R.V. genotyping, and contributed to the analysis of the results. R.D. managed the study at GlaxoSmithKline Vaccines and contributed to the analysis, interpretation and critically reviewed the study report. All authors had access to the data and participated in the drafting, review and approval of the manuscript. The corresponding author took final responsibility for submitting the manuscript.
