Hospital leads trial for care of babies born prematurely

A CORK hospital is leading in an international trial to try to establish the most appropriate treatment for babies who suffer from low blood pressure and low blood flow to the brain as a result of being born too early.

These babies, of whom up to one in five does not survive, are statistically at greater risk of brain injury, including a bleed into the brain tissue, because the structure of their blood vessels is not as robust as a baby delivered at full term.

Dr Gene Dempsey, a consultant neonatologist at Cork University Maternity Hospital (CUMH), said the standard treatment for these newborns — born before 28 weeks’ gestation — is to treat them for low blood pressure but this approach may not necessarily improve blood flow to the vital organs, including the brain.

“When babies have low blood pressure, the assumption is that the blood flow is low. Some of the cardiovascular support medications we use may improve the blood pressure but we don’t know if it is improving the blood flow. We are not certain if this is the case,” Dr Dempsey said.

Current treatment consists of administering dopamine, a drug which can increase blood pressure but Dr Dempsey said there were few studies addressing the long-term outcome associated with this intervention. This study plans to follow up the babies on a long-term basis to address this question.

Dr Dempsey said some of the medications used for the management of extremely premature newborns with hypotension (abnormally low blood pressure) had “crept in from the adult literature but had not been validated in newborns” and that the trial would examine whether medication was effective in these infants and whether it was possible to develop a standardised approach to treatment.

“We will look to see if we can isolate those who do need medication from those who don’t and we will look at whether dopamine is effective or not. At the moment we can not say it’s not, but there is enough uncertainty,” Dr Dempsey said.

The HIP (Hypotension in the Preterm Infant) trial will be seeking to recruit 750 ELGANS (Extremely Low Gestational Age Newborns) over the next three to four years. The infants enrolled will have blood pressure less than their gestational age. Approximately half will be treated with normal saline and dopamine and the other half will be given normal saline and a placebo — until their treating clinician decides there are signs that warrant other intervention.

Patients will be continually observed and monitoring will include ultrasounds of the heart to see if it is pumping correctly and also, brainwave analysis to monitor brain activity. Dr Dempsey said they are trying to determine what the most appropriate method of intervention for these infants is.

“Despite years of intervening, the actual criteria of when to intervene are not clear. We are trying to come up with a better way of diagnosis and treatment for these babies who have significant morbidity (high incidence of disease) and mortality of 15-20%,” Dr Dempsey said.

The HIP trial is EU-funded and multi-centred, taking place in Cork, Dublin, Belgium, Czech Republic and Canada. It includes 13 research groups and involves experts in the field of neonatology, scientists, neurophysiologists, pharmacologists and business.