ORACLE 7 Year Follow Up

Question 1

Who was eligible for recruitment into this trial?

Answer 1

Children of women in the ORACLE I trial, 7 years following delivery

Question 2

What was the recruitment rate?

How many eligible children were recruited into the ORACLE 7 year follow up trial?

Answer 2

75%

3298 children

Question 3

How was functional impairment defined in the ORACLE 7 year follow up trial?

Answer 3

The presence of any level of functional impairment (severe, moderate or mild) derived from the mark III Multi-Attribute Health Status classification system

Question 4

What was the main outcome of the ORACLE 7 year follow up trial?

Answer 4

NO difference in the proportion of children with any functional impairment in any of the four treatment arms

Question 5

When was the ORACLE 7 year follow up trial published?

Answer 5

2008

Question 6

What were two non-significant findings of the trial

To be interpreted with caution

Answer 6

Erythromycin: improvement in respiratory function

Augmentin: more children reported to have other bowel problems e.g. hospital admission for constipation, diarrhoea or stomach troubles, or under care of doctor for bowel problems