El‐Saiedi 2013.
Study characteristics | ||
Methods | Randomised, placebo‐controlled, single‐centre study; table block randomisation stratified by clinical centre. No blinding reported. | |
Participants | 86 patients (range 4 months to 6 years of age; mean age of 2.1 ± 1.3 years in the IVIG group versus 3.3 ± 1.9 years in the placebo group) with acute‐onset dilated cardiomyopathy, LVSF less than 20%, less than 6 months duration of cardiac symptoms at time of randomisation. Exclusion criteria: neonates, history of cardiac symptoms since birth | |
Interventions | Treatment of 1 g/kg IVIG (VIGAM‐S. , 2.5 g and 5 g, Bio Products Laboratory Limited) each day for 2 consecutive days versus regular glucose 5% IV fluids 10 mL/kg repeated on 2 consecutive days | |
Outcomes | Primary endpoint was change in LVSF and LVEDD from baseline to 6 months post randomisation assessed by echocardiography. Secondary endpoint was survival versus death. | |
Notes | Funding: not reported Language of publication: English |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used a "random table block stratified by clinical center" |
Allocation concealment (selection bias) | Low risk | Third party managed group assignment. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo used, and both groups received the same follow‐up. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All participants received the same follow‐up; survival vs death was hard endpoint. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number of participants lost to follow‐up was not reported. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information reported; data on SF are shown in Figure 2, but numbers are not provided. |