| Methods |
Randomised controlled trial. Method of randomisation not stated. Blinding of intervention and outcome assessment was not stated. Analysis was not performed by intention to treat (see notes). Follow‐up incomplete (see notes). |
| Participants |
Multicentre trial conducted in the USA from 1974 for unstated duration. Enrolled: 63 subjects aged < 1month with virologically confirmed HSV infection.
Number eligible for enrolment not stated. Exclusions were not stated.
Characteristics of participants were similar in relation to sex, gestational age, duration of disease prior to diagnosis, and category of HSV disease in treatment and placebo groups. (Vidarabine: 4 SEM, 10 CNS, 14 disseminated; Placebo: 9 SEM,6 CNS, 13 disseminated). |
| Interventions |
Treatment group: intravenous vidarabine 15mg/kg/day over 12hrs for 10 days (n=31 enrolled, 28 analysed).
Control group: intravenous placebo (n= 32 enrolled, 28 analysed). |
| Outcomes |
All outcomes were dichotomous variables. Primary outcomes:
mortality within the first year of life, progression of HSV disease while on treatment,
neurodevelopmental sequlae at about 1 year. Secondary outcomes: presence or absence of
nephrotoxicity, bone marow suppression,
nausea, vomiting, diarrhoea, acute neurologic toxicity, hepatic dysfunction.
Mortality and neurodevelopmental morbidity were analysed according to the category of HSV disease. Mortality at one year was also analysed by gestational age (preterm < 37 weeks vs. term). |
| Notes |
Seven infants were excluded post randomisation, 4 from the placebo were given vidarabine because of progressive herpetic disease, 2 from the vidarabine group received a higher than specified dose and one from the vidarabine group required a second course of therapy. Study run through NIAID, USA. Drug and placebo supplied by Warner‐Lambert/ Parke‐Davis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
