Clinical Research Directory

Hypernatremia Fluid Therapy in Childhood Diarrhoea

Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Summary

Hypernatremic dehydration is a life-threatening condition, particularly in children under two years of age, with mortality rates reaching up to as high as 19%. Infants are highly susceptible due to immature renal function, increased insensible water loss, and limited ability to express thirst. Severe hypernatremia can cause cerebral complications such as brain shrinkage, haemorrhage, seizures, paralysis, and encephalopathy. Furthermore, rapid or improperly managed fluid and electrolyte treatment can increase the risk of cerebral oedema and death. Although gradual sodium correction is widely recommended for hypernatremia, the optimal rate, route, and type of fluid therapy remain uncertain. Current treatment practices vary and no standardized protocol has been validated in randomized clinical trials for young children. This gap contributes to persistently high mortality and neurological morbidity. The goal of this clinical trial is to determine whether oral rehydration therapy is non-inferior to intravenous fluid therapy in the management of hypernatremic dehydration among children under five years of age with diarrhoea. The main questions it aims to answer are: Does oral rehydration therapy result in mortality rates comparable to those of intravenous fluid therapy among children with hypernatremic dehydration? Does oral rehydration therapy achieve safe correction of serum sodium levels and comparable neurological and clinical outcomes relative to intravenous fluid therapy? Researchers will compare oral rehydration therapy using oral rehydration salt (ORS) solution with intravenous fluid therapy using half-strength acetate in 5% dextrose to determine whether oral therapy is non-inferior to intravenous therapy in reducing mortality and improving clinical outcomes. Total 268 participants will: Be randomly assigned to 1:1 to receive either oral rehydration therapy or intravenous fluid therapy. Receive standardized fluid volumes calculated according to paediatric treatment protocols. Undergo clinical assessments and laboratory investigations, including serial serum sodium measurements, during hospitalization. Be monitored for adverse outcomes, including convulsions, fluid overload, and renal impairment. Have neurological status assessed using the Glasgow Coma Scale (GCS) on admission and at discharge. Attend follow-up assessments at 1 month and 6 months after discharge for neurodevelopmental evaluation using the Denver Developmental Screening Test II.

Official title: Oral Versus Intravenous Fluid Therapy for Hypernatremic Dehydration in Children Under Five With Diarrhoea: A Randomized, Controlled, Non-Inferiority Trial

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