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Randomized controlled trial of 4-hour versus 24-hour nasogastric rehydration in children with acute gastroenteritis and moderate dehydration

Randomized controlled trial of the clinical efficacy and safety of 4-hour nasogastric rehydration in the Emergency Department versus 24-hour nasogastric rehydration in hospital in children with acute viral gastroenteritis and moderate dehydration

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000737033
Enrollment
254
Registered
2010-09-03
Start date
2001-05-15
Completion date
2003-11-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Objectives: To compare the efficacy of two nasogastric rehydration regimens in children with acute viral gastroenteritis. Patients and methods: Children aged 6-72 months with acute viral gastroenteritis and moderate dehydration were recruited from Emergency Departments (ED) at two metropolitan pediatric teaching hospitals. After a clinical assessment of the degree of dehydration, patients were randomized to receive either standard nasogastric rehydration (SNR) over 24 hours in the hospital ward, or rapid nasogastric rehydration (RNR) over 4 hours in the ED. Primary treatment failure was defined as weight loss of >2%, compared to the admission weight. Secondary treatment failure was defined as the need for (re-)admission to hospital, insertion of an intravenous line for rehydration or inability to tolerate nasogastric rehydration. Results: Of 9331 children with acute gastroenteritis screened, 228 children were recruited and randomized (RNR 119 [52.2%], SNR 109 [47.8%]). Baseline characteristics for both groups were similar. All patients made a full recovery without severe adverse events. Primary failure rate at 24 hrs was similar for RNR 12.6% (95% confidence interval [CI]; 6.6–18.6) and SNR 8.3% (95%CI; 3.1–13.5); p=0.12. Secondary treatment failure was more common in SNR patients 44% (95% CI; 34.6–53.4) vs RNR 31.1% (95%CI; 22.0–38.6); p=0.03. Discharge from the ED after RNR failed in 28 (23.5%) patients, and 9 (7.5%) were re-admitted within 24 hrs. Conclusion: Primary treatment failure and clinical outcomes were similar for RNR and SNR. While RNR generally reduced need for hospitalization, discharge home from the ED failed in about one quarter of patients.

Interventions

Nasogastric rehdydration is a standard treatment of mild to moderate dehydration in patients with gastroenteritis. A nasogastric tube is inserted through the nose into the stomach and oral rehydration fluid slowly infused, as clinically indicated. Patients will be randomised to receive one of two nasogastric rehydration regimens: 1 - Rapid nasogastric rehydration (RNR) over 4 hours (100 ml/kg total); or 2 - Slow nasogastric rehydration (SNR) over 24 hours (replacement of 5-7% body weight over 2

Nasogastric rehdydration is a standard treatment of mild to moderate dehydration in patients with gastroenteritis. A nasogastric tube is inserted through the nose into the stomach and oral rehydration fluid slowly infused, as clinically indicated. Patients will be randomised to receive one of two nasogastric rehydration regimens: 1 - Rapid nasogastric rehydration (RNR) over 4 hours (100 ml/kg total); or 2 - Slow nasogastric rehydration (SNR) over 24 hours (replacement of 5-7% body weight over 24 hours)

Sponsors

Royal Children's Hospital Melbourne
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
6 Months to 6 Years
Healthy volunteers
No

Inclusion criteria

Children with acute gastroenteritis and moderate dehydration presenting to the Emergency Department at 2 metropolitan paediatric teaching hospitals Acute diarrhoea (non-bloody) Moderate dehydration defined as 3 clinical signs (based on Gorelick study criteria)

Exclusion criteria

1 - Bloody diarrhoea, 2 - Severe dehydration (dehydration score > 7) 3 - Mild dehydration (dehydration score < 3) 4 - Unable to obtain written informed consent, 5 - Patient living outside area covered by hospital-in-the-home (part of follow-up at 24 hrs and 7 days)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026