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Table 5 Range of estimated sample sizes

From: The INIS Study. International Neonatal Immunotherapy Study: non-specific intravenous immunoglobulin therapy for suspected or proven neonatal sepsis: an international, placebo controlled, multicentre randomised trial

Mortality or major morbidity in control group

Mortality or major morbidity in IVIG group

Relative risk reduction

Total sample size required to detect difference with 95% confidence

   

80% power

90% power

30%

26%

13%

4,052

5,392

30%

25%

17%

2,580

3,428

30%

20%

33%

626

824

25%

21%

16%

3,572

4,748

25%

20%

20%

2,266

3,006

25%

15%

40%

540

708

20%

16%

20%

2,994

3,972

20%

15%

25%

1,890

2,502

20%

12.5%

37.5%

810

1,066

15%

12%

20%

4,204

5,582

15%

10%

33%

1,450

1,914

12%

9%

25%

3,408

4,516

10%

7.5%

25%

4,166

5,524