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.