ORACLE Children Study - 18 September 2008

RCPCH response to the ORACLE Children Study - 18 September 2008

The Royal College of Paediatrics and Child Health (RCPCH) has noted the results of this important study published by the Lancet on 18 September. This carefully conducted trial was designed to investigate the hypothesis that the use of antibiotics in premature labour would improve the outcome for babies.

The ORACLE II paper reports on the 7 year follow up of a randomised controlled trial of the use of erythromycin and/or co-amoxiclav for women presenting in spontaneous preterm labour with intact membranes. The study unexpectedly found that after prescription of antibiotics there was a small increase in the number of children later reported by their parents as having functional impairment, or cerebral palsy. The ORACLE I paper reported that these findings were not replicated in the group of children whose mothers' membranes had ruptured. It is considered unlikely that this is directly an effect of the antibiotics. These results warrant discussion and further investigation.

Some important principles have emerged. Firstly the study confirms existing practice that women in spontaneous preterm labour whose membranes have not ruptured should not routinely be given antibiotics. Secondly, the findings confirm the principle that antibiotics should only be used where there is proven infection or good evidence to suggest that there is a risk of infection developing.

Infection arising during preterm labour and pregnancy is dangerous to both mother and baby and if this develops it is extremely important that antibiotics are considered.

Cerebral palsy is not a disease but is a non-progressive condition in which the brain's ability to control movement is impaired. It ranges from very mild to severe.  We know that the risks are higher in children born prematurely, but, in terms of numbers, most children who are diagnosed with cerebral palsy are born at term. We still do not know what causes cerebral palsy in the majority of cases. It is therefore very important that further research is undertaken to understand the mechanisms behind the findings of this study.

To view the study in The Lancet - click here
To view the letter from the Chief Medical Officer - click here