Improving clinical care for the smallest patients

Investigator-led clinical trials in Ireland are seeking to meet the medical needs of tiny babies

There are few sights as heartrending as that of a newborn baby surrounded by equipment in a neonatal intensive care unit (NICU). These tiny patients have particular needs, and that is why some investigator-led clinical studies in Ireland are looking to develop better ways to cater for them, including how best to prevent infections being introduced from the equipment itself.

Prof Colm O'Donnell, a consultant neonatologist at the National Maternity Hospital at Holles Street in Dublin, recently led a study to compare antiseptic solutions used on premature babies when inserting central venous catheters.

“Getting these tiny babies to grow is critically important,” explains O’Donnell, who is director of clinical research at the National Children’s Research Centre (NCRC).

“We often use central lines, mainly for intravenous feeding, but the downside is that the babies are at risk of getting catheter-related bloodstream infections, [so] when you insert the line, you take sterile precautions to reduce the chances of infection.”


Antiseptic solution

One precaution is to clean the entry site with an antiseptic agent, and O’Donnell and colleagues have just compared two commonly-used antiseptic solutions in a trial at the NMH and the Coombe Women & Infants University Hospital. It involved more than 300 babies who were born before 31 weeks’ gestation.

The results showed no difference in infection rates using either solution, but that one solution carried a small risk of interfering with thyroid function.

“This is the biggest trial that has been done on these antiseptic methods in the past 15 years, and I think recommendations will be made on the basis of our findings,” says O’Donnell. The study was funded by the NCRC and sponsored by the UCD Clinical Research Centre.

“The companies that make these products had no role in the trial whatsoever. Though there is no financial imperative for anybody to do these studies, it is an important study that will improve the care of small babies.”

Seizure detection

Another clinical trial, which was led by researchers at

University College Cork

, is testing a cot-side monitor to detect brain seizures in babies in the NICU.

“Some babies are at risk of having brain seizures, but you can’t always tell just by looking at them that they are seizing. And if we don’t know when they are seizing, we don’t know when to treat them,” explains Geraldine Boylan, professor of neonatal physiology at UCC and a director of the Irish Centre For Fetal and Neonatal Translational (INFANT) research centre.

To alert clinical staff to a problem, Boylan and her colleagues have developed specialised software that can track the electrical signals coming from small electrode pads placed on the baby’s head: it automatically detects when a seizure is starting, and sends an alert.

The work, which was funded by agencies such as the Health Research Board, Science Foundation Ireland and the Wellcome Trust, has led to a clinical trial of the technology in NICUs in Cork, Dublin, London, Sweden and the Netherlands, and Boylan is enthusiastic about the "encouraging" results to date.

“We would like this technology to be next to every cot in every NICU in the world, keeping an eye on these babies’ brains around the clock,” says Boylan.

“And we hope that it will allow brain monitoring in these tiny babies to become as commonplace as monitoring their heartbeat.”

Consent and ethics

One of the most important requirements for clinical research studies in babies is getting informed consent from parents, often in critical situations, according to Boylan.

“This can be difficult and it needs to be handled sensitively by the research team,” she says, stressing that parents and families generally want to help.

“They are fantastic, and we can’t thank them enough for their engagement at a really worrying time for the family,” she says.

O’Donnell has also been blown away by the “overwhelmingly positive” response from parents to allow their children to be part of studies to improve clinical care. “Without the participation and support of the families, these clinical trials cannot happen,” he says.

“It is potentially quite stressful to consider participation in a trial when your baby has been or will be born prematurely; there is no doubt about that. However, people understand that the startling improvements in neonatal medicine in recent decades are due to clinical research, and clinical trials in particular.

“Families support this research for altruistic reasons: they want to improve medical care for babies and families who will find themselves in their situation in the future.”

As for the ethics of whether they should be carrying out clinical studies on babies, he takes a pragmatic approach.

“People correctly debate the ethics of doing research in babies and children, but what they don’t talk about quite so much is the ethics of not doing research in babies and children,” says O’Donnell.

“If you make it difficult to do research in babies, you end up treating them with therapies that are far less well tested than in other age groups. It suggests that a lesser standard of proof that treatments work or are safe is somehow okay for babies. That’s unacceptable to me.

“We do these studies to try to improve the care of babies, not just in an individual hospital or in Ireland but everywhere. Well-run clinical studies make a very valuable contribution that shouldn’t be underestimated.”