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. 2006 Jul 19;2006(3):CD004390. doi: 10.1002/14651858.CD004390.pub2

Santosham 1982ii.

Methods Randomized controlled trial
Length of follow up: hospital discharge
Withdrawals and losses to follow up: none
Score on Jadad scale: 2
Participants Number of participants: 52
Inclusion criteria: those hospitalized for less than 5 days with dehydration > = 5% secondary to acute diarrhea; length and weight of the children had to be above the third percentile; any child who was considered to be severely dehydrated or have signs of shock was given IV Ringers lactate before being assigned to the study
Exclusion criteria: none stated
Interventions 1. IV (31 participants): replace deficit over 8 h with 0.45% saline containing 5% glucose and 20 mmol/L of potassium chloride, then maintained with oral Pedialyte
 2. ORT (66 participants): replace deficit over 8 h; 33 participants received ORT of 50 mmol/L sodium and 30 received strawberry‐flavored ORT of 90 mmol/L sodium; route of administration: oral
Patients were not allowed additional water within 24 h if diarrhea had not stopped within the 24 h; ORT patients were given a soy‐based lactose‐free formula (Isomil) diluted 1:1 with water after diarrhea stopped, followed by a regular diet 24 h later; IV patients were given Pedialyte for 12 h after diarrhea stopped then Isomil followed by regular diet; all severely dehydrated patients were given Ringer's lactate (20 mL/kg/h) until blood pressure and pulse returned to normal prior to be assigned to a treatment protocol; subsequently rehydration and maintenance therapy completed according to randomly assigned intervention
Outcomes 1. Failures (refused ORT; initial signs of dehydration after 8 h; dehydration returned during maintenance phase)
 2. Frequency of stools
 3. Weight gain
 4. Complications
 5. Side effects
 6. Duration of diarrhea
 7. Sodium concentration
 8. Total fluid intake at 8 h and for duration of illness
Notes Trial location: USA
Source of funding: Pennwalt Corp., Ross Labs, Pan American Health Org., and the NIH