Variables Associated With Intravenous Rehydration and Hospitalization in Children With Acute Gastroenteritis: A Secondary Analysis of 2 Randomized Clinical Trials

Abstract

Importance: Despite guidelines endorsing oral rehydration therapy, intravenous fluids are commonly administered to children with acute gastroenteritis in high-income countries.

Objective: To identify factors associated with intravenous fluid administration and hospitalization in children with acute gastroenteritis.

Design, setting, and participants: This study is a planned secondary analysis of the Pediatric Emergency Research Canada (PERC) and Pediatric Emergency Care Applied Research Network (PECARN) probiotic trials. Participants include children aged 3 to 48 months with 3 or more watery stools in 24 hours between November 5, 2013, and April 7, 2017, for the PERC study and July 8, 2014, and June 23, 2017, for the PECARN Study. Children were from 16 pediatric emergency departments throughout Canada (6) and the US (10). Data were analyzed from November 2, 2018, to March 16, 2021.

Exposures: Sex, age, preceding health care visit, distance between home and hospital, country (US vs Canada), frequency and duration of vomiting and diarrhea, presence of fever, Clinical Dehydration Scale score, oral ondansetron followed by oral rehydration therapy, and infectious agent.

Main outcomes and measures: Intravenous fluid administration and hospitalization.

Results: This secondary analysis of 2 randomized clinical trials included 1846 children (mean [SD] age, 19.1 [11.4] months; 1007 boys [54.6%]), of whom 534 of 1846 (28.9%) received oral ondansetron, 240 of 1846 (13.0%) received intravenous rehydration, and 67 of 1846 (3.6%) were hospitalized. The following were independently associated with intravenous rehydration: higher Clinical Dehydration Scale score (mild to moderate vs none, odds ratio [OR], 8.73; 95% CI, 5.81-13.13; and severe vs none, OR, 34.15; 95% CI, 13.45-86.73); country (US vs Canada, OR, 6.76; 95% CI, 3.15-14.49); prior health care visit with intravenous fluids (OR, 4.55; 95% CI, 1.32-15.72); and frequency of vomiting (per 5 episodes, OR, 1.66; 95% CI, 1.39-1.99). The following were independently associated with hospitalization: higher Clinical Dehydration Scale score (mild to moderate vs none, OR, 11.10; 95% CI, 5.05-24.38; and severe vs none, OR, 23.55; 95% CI, 7.09-78.25) and country (US vs Canada, OR, 3.37; 95% CI, 1.36-8.40). Oral ondansetron was associated with reduced odds of intravenous rehydration (OR, 0.21; 95% CI, 0.13-0.32) and hospitalization (OR, 0.44; 95% CI, 0.21-0.89).

Conclusions and relevance: Intravenous rehydration and hospitalization were associated with clinical evidence of dehydration and lack of an oral ondansetron-supported oral rehydration period. Strategies focusing on oral ondansetron administration followed by oral rehydration therapy in children with dehydration may reduce the reliance on intravenous rehydration and hospitalization.

Trial registration: ClinicalTrials.gov Identifiers: NCT01853124 (PERC) and NCT01773967 (PECARN).

Conflict of interest statement

Conflict of Interest Disclosures: Dr Freedman reported receiving nonfinancial support from Lallemand Health Solutions, the Provincial Laboratory for Public Health, Luminex Corporation, and Copan Italia, and receiving grants from the Canadian Institutes for Health Research and Alberta Children’s Hospital Foundation. Dr Freedman reported providing consulting services to RedHill Biopharma LTD and Takeda Pharmaceutical Company during the conduct of the study. Dr Powell reported receiving grants from the National Institute of Child Health and Human Development (NICHD) via subcontract and grants from the National Institutes of Health (NIH) via subcontract outside the submitted work. Dr Schnadower reported receiving research grants from NIH/NICHD and nonfinancial support from iHealth Inc during the conduct of the study. Dr Casper reported receiving grants from the NICHD and from the Health Resources and Services Administration (HRSA) during the conduct of the study. Dr Roskind reported receiving grants from the NICHD during the conduct of the study. Dr Olsen reported receiving grants from the NICHD during the conduct of the study. Dr Tarr reported receiving grants from Washington University and the NIH during the conduct of the study. Dr Mahajan reported receiving grants from the NICHD during the conduct of the study. Dr Vance reported receiving grants from the NICHD and the NIH during the conduct of the study. Dr Sapien reported receiving grants from the NIH during the conduct of the study and from the HRSA outside the submitted work. Dr O'Connell reported receiving grants from the NIH during the conduct of the study. Dr Bhatt reported receiving grants from the NIH during the conduct of the study.

Figures

Figure 1.. Flow Diagram of Patients Analyzed from PERC and PECARN Cohorts

IV indicates intravenous; PECARN, Pediatric Emergency Care Applied Research Network; and PERC, Pediatric Emergency Research Canada.

Figure 2.. Adjusted Odds Ratios (ORs) From Multivariable Models of Variables Associated With Intravenous (IV) Rehydration

Estimates for infectious agent are from a secondary model using 1489 participants for whom stool testing results were available. The “other” category included isolated parasites in the absence of other infectious agents of interest (n = 11) and parasite or virus codetection (n = 7). Estimates for a preceding health care practitioner visit with no IV rehydration and a preceding health care practitioner visit with IV rehydration are from a secondary model using 1690 participants with information about prior health care practitioner visits. All other estimates are from a model using 1692 participants in which the largest variance inflation factor was 1.28 and intraclass correlation within sites was 0.09. ED indicates emergency department.

Figure 3.. Adjusted Odds Ratios (ORs) From Multivariable Models of Variables Associated With Hospitalization From the Emergency Department (ED) Index Visit

Estimates for infectious agent are from a secondary model using 1471 participants for whom stool testing results were available and excluding those with parasites. Estimates for a preceding health care practitioner visit with no intravenous (IV) rehydration and a preceding health care practitioner visit with IV rehydration are from a secondary model using 1690 participants with information about prior visits. All other estimates are from a model using 1692 participants in which the largest variance inflation factor was 1.28. Intraclass correlation within sites was 0.09.