Low Osmolar Oral Rehydration Salts Solution in the Treatment of Acute Watery Diarrhoea in Neonates and Young Infants: A Randomized, Controlled Clinical Trial

To compare the efficacy and safety of low osmolar oral rehydration salts solution (ORS-75) (mmol/L: Na+ 75, osmolarity 245) with that of World Health Organization-recommended ORS (ORS-90) (mmol/L: Na+ 90, osmolarity 311 ) in the treatment of acute watery diarrhoea in neonates and very young infants, a randomized double-blind, controlled clinical trial was carried out at the Clinical Research and Service Centre of ICDDR,B: Centre for Health and Population Research, Dhaka, Bangladesh, during January 1998-December 1999. Infants, aged ≤2 months, presenting with a history of watery diarrhoea of ≤72 hours, with no or some dehydration and without any systemic illness, were randomly assigned to receive either ORS-75 or ORS-90 for the correction and subsequent prevention of dehydration. Infants were studied for a maximum of five days. Total stool output, stool frequency, and requirement for ORS were outcome measures. Serum electrolytes were measured at 24 hours after admission to monitor serum sodium imbalance. Seventy-three infants received ORS-75, and 71 received ORS-90. Both the groups were comparable in their baseline characteristics. Diarrhoea resolved within five days in 53% and 66% of infants receiving ORS-75 and ORS-90 respectively (p=0.3). Total stool volume [median (inter-quartile range) 132 (65-280) vs 139 (70-259) g/kg, p=0.9], during the study period, was not significantly different between the two groups. Total stool frequency [31 (16-51) vs 35 (16-53), p=0.9] and total ORS intake [192 (96-374) vs 209 (134-317) mL/kg, p=0.7] were similar between the groups. No infants developed late evidence of hypernatraemia, irrespective of treatment. The results of the study indicate that ORS-75 is as safe as standard ORS-90 in the treatment of acute watery diarrhoea in neo-nates and very young infants and is effective in correcting and preventing dehydration.

Keywords
Diarrhoea, Acute; Diarrhoea, Watery; Oral rehydration solution; Oral rehydration therapy; Osmolarity; Randomized controlled trials; Double-blind method; Clinical trials; Bangladesh