ORACLE I

Question 1

When was the ORACLE I trial published?

Answer 1

2001

Question 2

How many women were recruited to the ORACLE I trial?

Answer 2

4286 women

Question 3

What were the four treatment arms of the ORACLE I Trial?

Answer 3

Erythromycin 250mg qid po for 10/7
Augmentin 325mg qid po for 10/7
Both above antibiotics for 10/7
No antibiotics

Question 4

What was the primary outcome measure in the ORACLE Trial?

Answer 4

Composite of neonatal death, chronic lung disease, or major cerebral abnormality on USS before discharge

Question 5

Use of erythromycin was associated with five outcomes. What were they?

Answer 5

Prolongation of pregnancy
Reductions in neonatal treatment with surfactant
Decrease in oxygen dependence at 28 days of age and older
Fewer major cerebral abnormalities on USS before discharge
Fewer positive blood cultures

Question 6

What was a negative outcome associated with Augmentin?

Answer 6

Statistically significant increase in rate of necrotising enterocolitis

Question 7

What type of trial was this?

Answer 7

Multicentre, blinded randomised control trial