Singhi 1995.
Methods | Setting: Hospital Inpatient department Study design: Randomised, parallel group, single‐centre, controlled trial Location: India Timing and duration: not stated Source of funding: not stated |
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Participants | Children with a diagnosis of bacterial meningitis were eligible for inclusion. Children with heart disease, respiratory illness, gastrointestinal disease, renal disease, central nervous system disease, malnutrition (less than 60% of weight expected for age), endocrinopathy, malignancy, immunodeficiency, or who had received previous anticonvulsant therapy were excluded Age: 2 months to 7 years |
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Interventions | 65% calculated maintenance fluid requirement, given as intravenous 1/5th normal saline in 5% dextrose for 24 hours, followed by "a gradual liberalisation at a rate of 10 ml/kg/8 hours after 24 hours of hospital stay if serum sodium and plasma osmolality had returned to normal and if there were no clinical signs of dehydration versus maintenance fluid requirements (110 ml/kg for first 10 kg, 50 ml/kg for next 10 kg and 25 ml/kg for subsequent weight) given as intravenously and comprising 1/5th normal saline in 5% dextrose" as long as they required intravenous fluids | |
Outcomes | Intact survival with sequelae Death Total body water Extracellular water Serum sodium plasma osmolality Urine sodium Urine osmolality | |
Notes | Trial was stopped prematurely "when a trend toward poor outcome in the restricted‐fluid group became obvious" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Use of a list or table. Treatment and control groups were comparable at study entry |
Allocation concealment (selection bias) | Unclear risk | Unclear, with the use of a list or table |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Clearly neither participant's nor treatment providers blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Clearly neither outcome assessors, participants nor treatment providers blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Appeared to account for all participants |
Selective reporting (reporting bias) | High risk | Mixed neurological outcomes and complications, so some important outcomes unavailable |
Other bias | High risk | Study was stopped prematurely, with no a priori stopping rules, with a "trend towards poor outcome" in one group |
CSF: cerebrospinal fluid