Background Frequent and severe gastrointestinal disturbances have been reported with the use of diazoxide in adults and older children. However, no studies have investigated the incidence of necrotising enterocolitis (NEC) in diazoxide-exposed newborns.
Objective To evaluate a possible association between diazoxide treatment for neonatal hypoglycaemia and the occurrence of NEC.
Design Multicentre retrospective cohort study.
Setting Three tertiary neonatal intensive care units in Toronto, Canada.
Patients All patients treated with diazoxide for persistent hypoglycaemia between July 2012 and June 2017 were included. Overall incidence of NEC during those years on the participating units was obtained for comparison from the Canadian Neonatal Network database.
Main outcome Incidence of NEC after diazoxide exposure.
Results Fifty-five neonates were exposed to diazoxide during the study period. Eighteen patients (33%) showed signs of feeding intolerance, and 7 developed NEC (13%). A diagnosis of NEC was more prevalent in the diazoxide-exposed, as compared with non-exposed infants of similar gestational age (OR 5.07, 95% CI 2.27 to 11.27; p<0.001), and greatest among infants born at 33–36 weeks’ gestation (OR 13.76, 95% CI 3.77 to 50.23; p<0.001). All but one of the neonates diagnosed with NEC developed the disease within 7 days from initiation of diazoxide treatment.
Conclusion The present data suggest a possible association between diazoxide exposure and the development of NEC in neonates. Further evaluation of the diazoxide-associated risk of NEC in neonates treated for persistent hypoglycaemia is warranted.
- intensive care
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Contributors JB conceptualised and designed the study. He was the primary investigator in The Hospital for the Sick Children and collaborated with obtaining the Research Ethic Board approval and the Data Transfer Agreement among sites. He also reviewed and revised the manuscript for important intellectual content. LAP conceptualised and designed the study, designed the data collection instruments, collected data, carried out the initial analysis, drafted the initial manuscript, and reviewed and revised the manuscript. MC designed the data collection instruments, collected the data, and reviewed and revised the manuscript. AJ and DEW were the primary investigators in Mount Sinai Hospital and Sunnybrook Health Sciences Center, respectively. They collaborated with obtaining the Research Ethic Board approval and the Data Transfer Agreement among sites. They also coordinated and supervised the data collection, and critically reviewed the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study was approved by the institutional research ethics boards (MSH REB: 17–0291-C, SBHC: REB 017–2018 and HSC REB 1000059064).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.
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