Santosham 1982ii.
| Methods | Randomized controlled trial Length of follow up: hospital discharge Withdrawals and losses to follow up: none Score on Jadad scale: 2 |
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| 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 |
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| 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 |
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| 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 |
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