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. 2020 Aug 19;2020(8):CD004370. doi: 10.1002/14651858.CD004370.pub4

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
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.