Clinical Research Directory

Hypernatremia Fluid Therapy in Childhood Diarrhoea

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.

Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children

This randomized controlled trial will compare Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) in children aged 1-5 years with acute watery diarrhea. Participants will receive one of the probiotic treatments along with standard therapy including oral rehydration solution and zinc supplementation. The study will evaluate the duration of diarrhea, stool frequency, and stool consistency.

Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3

THIS STUDY WILL BE CONDUCTED ON OPD PATIENTS IN CENTRAL PARK TEACHING HOSPITAL LAHORE TO SEE THE EFFECT OF PROBIOTICS ON DIARRHEA ALL PATIENTS INCLUDED WILL HAVE ACUTE WATERY DIARRHEA AND THE OUTCOME WILL BE CHECKED ON THE THIRD DAY OF ADMISSION

Comparison of Low Osmolar ORS and ReSoMal for Treating Acute Watery Diarrhea in Severely Malnourished Children Aged 6 Months to 5 Years

Acute watery diarrhea is a common and serious health issue in children, especially in those who are severely malnourished. These children are at a much higher risk of complications such as dehydration, electrolyte imbalances, and even death. Oral Rehydration Solutions (ORS) are a widely used treatment to prevent and correct dehydration in such children. However, there are different types of ORS, and it is still unclear which one is more effective and safer for use in severely malnourished children. This clinical study is being conducted at The Children's Hospital, Lahore, to compare two different types of ORS: low osmolar ORS and ReSoMal (a special rehydration solution designed for malnourished children). The aim is to determine which solution is more effective in correcting low potassium levels (a common problem in these children) and to identify which one has fewer side effects, particularly problems like low or high sodium levels that can be dangerous. A total of 72 children between 6 months and 5 years of age, all diagnosed with severe malnutrition and mild to moderate dehydration due to acute watery diarrhea, will be included in the study. They will be randomly assigned to receive either low osmolar ORS or ReSoMal. Blood tests will be done before and after the treatment to check for changes in electrolyte levels. The frequency of diarrhea and the child's overall response to treatment will also be recorded. The hypothesis of this study is that there is a significant difference in both effectiveness and side effects between the two ORS solutions. The results of this study will help doctors choose the safest and most effective ORS for treating diarrhea in severely malnourished children, improving care and potentially saving lives.