Objective-To develop a statistical method for defining clusters of necrotizing enterocolitis (NEC) cases in the neonatal intensive care unit (NICU).Study design-2782 infants, between 1996-2004, weighing 401-1500 grams at birth were included. NEC was defined as Bell stage II or III. Two statistical methods used to define "disease clusters" were: (1) modified scan test; (2) comparison of observed and expected incidence density rates (IDR) of NEC at each NICU.Results-The proportion of infants with NEC was similar between NICUs (7.1% vs. 7.7%; p=0.6) as was the expected IDR of NEC (1.39/1000 patient-days vs. 1.32/1000 patient-days, p=0.72). Twelve temporal clusters of NEC were identified in the NICUs combined, comprising 18% of 203 total NEC cases during the study period. No seasonal/secular trends were noted for NEC rates or identified clusters. Potential NEC clusters of ≥3 cases at either NICU had >75% chance of being a true NEC cluster.Conclusions-No operational definition of NEC cluster exists. This study introduced methods to be employed for prospective surveillance and guide studies to investigate etiologic relevance. Utilizing the proposed methods, statistically significant clusters (potential outbreaks) of NEC within NICUs can be identified early, providing early opportunity to implement cluster investigation protocols.
Keywords disease clusters; outbreaks; neonatal intensive care unit; very low birth weight infantsCorresponding Author: Jareen Meinzen-Derr, Ph.D., 3333 Burnet Ave, MLC 5041, Center for Epidemiology and Biostatistics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229-3039, Email: E-mail: jareen.meinzen-derr@cchmc.org.
Edited by Padbury and WFBThe authors declare no conflicts of interest.Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Necrotizing enterocolitis (NEC), the most common gastrointestinal emergency in the neonatal intensive care unit (NICU), is a sudden-onset life-threatening disease that occurs primarily in preterm infants. NEC affects approximately 6-10% of very low birthweight (VLBW) infants, 1-4 with nearly 90% of all NEC cases occurring among this population and a case-fatality rate as high as 20-40%. 5 The etiology of NEC is not clearly established, but appears to be multifactorial, involving enteral feeding, vascular or perfusion-related gastrointestinal compromise, and bacterial invasion. 6, 7 Cases appear to occur sporadically with reports of clusters or outbreaks. 8, 9 No formal or consistent approach has been applied to these reports, however, regarding the definition and timing of apparent outbreaks or the...