Clinical characteristics and prevalence of necrotizing enterocolitis among infants with dysphagia using SimplyThick
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INTRODUCTION: Infants who have dysphagia (difficulty swallowing) are often recommended thickened oral liquids, which can be easier to swallow and allow infants to continue feeding orally. In the last decade, a xanthan gum thickener, SimplyThick®, was commonly used in preterm infants with dysphagia because of its ability to thicken breast milk. In 2011, the FDA cautioned against the use of SimplyThick in preterm infants, because of case reports of necrotizing enterocolitis (NEC), a condition where the bowel becomes inflamed and can lead to intestinal perforation or necrosis, systemic infection, the failure of multiple organs and death (Moore, 2016; Press Announcements, 2011). However, since the FDA warning, there have been no studies examining the prevalence of necrotizing enterocolitis in infants who consume SimplyThick. AIMS: Among infants at BCH who used SimplyThick and other thickeners at <1-year old between October 1st, 2012- December 31st, 2015 to 1) describe the patients’ clinical characteristics, including indications for SimplyThick and other thickeners and 2) determine the prevalence of necrotizing enterocolitis and adverse effects. METHODS: We performed a retrospective chart review in infants who had been seen at Boston Children’s Hospital, and prescribed or recommended SimplyThick thickener under the age of 1 (defined as from 0 up to and including 12 months) from October 1, 2012 to December 31, 2015. We collected information from electronic medical records and an existing quality improvement database of infants who had an abnormal modified barium swallow study. We collected information regarding clinical variables (e.g. patient age, patient sex, patient weight, gestational age at birth, clinical indications), nutritional information, and outcomes (presence of NEC or other adverse effects). These data were entered into a REDCap database and analyzed using SAS statistical software. RESULTS: We identified 20 cases of infants meeting our inclusion criteria. The duration of follow-up ranged from 6 months to 9.3 months. This follow up was either until the case turned 12 months of age or 6 months after the use of SimplyThick if the age started SimplyThick was greater than 6 months old. Mean corrected age at the time that SimplyThick was started was 6.2 months (range, 2.7 to 10.6 months), and 6 (30%) were born preterm at a gestational age ranging from 24.7 to 36.5 weeks. In cases that eventually stopped using SimplyThick (14 cases, 70%), SimplyThick was continued for a mean duration of 42.1 weeks (range 1.1 to 117.1 weeks). The most common indications for SimplyThick were aspiration documented on a modified barium swallow test, dysphagia and GERD. The most common reasons for discontinuation of SimplyThick were no longer requiring thickened feeds, or needing to stop oral feeding. No cases of necrotizing enterocolitis were reported among the 20 subjects. No adverse effects of SimplyThick were reported. CONCLUSION: Among 20 infants started on SimplyThick at 6.2 months and followed for up to 6 to 9.3 months, there were no cases of necrotizing enterocolitis. Further data collection is required to confirm these findings.