The PROTECT Trial
The first – already three years in and being coordinated with the assistance of the National Health and Medical Research Council (NHMRC) Clinical Trial Centre at the University of Sydney – is trialling the ability of the well-established anti-inflammatory drug, pentoxifylline, to reduce the damage caused to preterm babies by severe inflammation.
“Currently there are no evidence-based medications that target the harmful inflammation that comes along with neonatal sepsis,” Professor Strunk said. “We need to do more than just treat these babies with antibiotics and supportive care.
“Working with our international colleagues, we’re trialling this old anti-inflammatory which has been around for about five decades. It has an excellent safety record, including in tiny babies, which is why we are comfortable using it in unwell preterm infants.
“Our pilot study at KEMH showed this drug was well-tolerated, without any adverse effects, and that it can be safely used in conjunction with other common medication in the NICU. We now hope to show it can help limit this long-term damage caused by inflammation, such as that caused by sepsis.”
The NHMRC-funded trial, under way in Australia, New Zealand, Singapore, and Taiwan, is halfway to its goal of recruiting 1,000 extremely preterm babies. Participating babies will be treated while in the NICU and then, once they turn two years of age, will be assessed to determine their developmental outcomes.
The PROTECT Trial
NICUs in Canada and Ireland have also joined the pentoxifylline study and will soon begin recruiting.
Given that extremely preterm babies with suspected sepsis represent a highly specialised population, involvement of sites in other countries will help reach the numbers needed for a large international trial.
Ancient skin-care treatment shows promise
The second international study being led by the neonatal team will trial the use of topical coconut oil – gently applied to the skin of extremely preterm babies – to improve skin integrity and help fight off sepsis. Set to kick off later this year, the trial will be conducted in 16 NICUs across Australia and New Zealand.
A pilot study, carried out in the KEMH NICU from 2016–2017, successfully improved the skin condition of participating babies and has since been adopted as routine practice at KEMH. Popular with both healthcare staff and parents, it has now been used on more than 700 very preterm babies.
“In extremely preterm infants the skin is very immature and its integrity deteriorates quickly after birth,” Professor Strunk said. “Those with the poorest skin condition end up with the highest incidence of sepsis. Despite this, we still don’t have any routine intervention available to maintain skin integrity and prevent sepsis.
“We also demonstrated that the principal antimicrobial fatty acid in coconut oil is highly active against common neonatal sepsis-causing bacteria, in concentrations present in the coconut oil we used.”
If the international trial is successful, Professor Strunk said application of coconut oil – used for millennia in Asian countries for newborn skin care – could become a standard part of the care of vulnerable premmies in high resource NICUs.
“If our hypothesis is confirmed, this widely available, low-cost intervention could be translated rapidly into routine clinical care,” he said.
“Importantly, it also offers an ideal opportunity to actively engage parents in the care of their infant. At KEMH we specifically encourage parents to participate, and this has led to noticeable increases in parental involvement and skin-to-skin care.”
Meet Isabella, pilot study participant
When KEMH specialists first suggested using coconut oil to treat the fragile skin of Kimberly Rohrlach’s extremely premature first-born child, Isabella, she thought it was more than a little weird.
The one-in-a-million baby who defied the odds
About the researchers
Research carried out by the Neonatal Infection and Immunity Team, led by Professor Strunk, focuses on the underlying factors which make extremely premature babies so vulnerable to infection, and on finding new ways to prevent and treat these infections more effectively.
The team – ranked in the top 10 preterm immunity research groups globally – formally joined Telethon Kids in 2019 and is now working on two large international clinical trials.
- The PROTECT Trial:
Can Pentoxifylline improve survival without disability in preterm infants with late-onset sepsis or necrotising enterocolitis
- COSI 2:
Topical coconut oil to reduce late-onset sepsis in extremely preterm infants