Can Pentoxifylline improve survival without disability in preterm infants with late-onset sepsis or necrotising enterocolitis – a pragmatic randomised controlled trial (The PROTECT Trial).
Lead investigators: Prof Karen Simmer, Clin Prof Tobias Strunk and Clin Prof Sanjay Patole
Summary: Sepsis and NEC are common complications of extremely early birth. These conditions also are the principal causes of systemic inflammation in preterm infants and increase the chances of brain injury and long-term disability.
In the PROTECT trial, we aim to find out if the addition of Pentoxifylline to standard treatment of bloodstream infections (sepsis) or bowel inflammation (necrotizing enterocolitis, NEC) can improve survival without disability in extremely preterm infants.
PROTECT is a large international, multicentre trial with 19 Neonatal Intensive Care Units currently participating in Australia, New Zealand, Singapore and Taiwan (and 3 Canadian units joining in 2020). The Neonatal Unit at King Edward Memorial Hospital is leading this study together with the NHMRC Clinical Trials Centre at the University of Sydney.
Funder: NHMRC
Registration ID: ACTRN12616000405415
For more information about the Protect Trial:
Pentoxifylline
Schueller SS, Unterasinger L, Kempf K, Strunk T, Berger A. Intravenous pentoxifylline is well tolerated in critically ill preterm infants with sepsis or necrotizing enterocolitis. Eur J Pediatrics 2020 (in print)
Senarathna S, Strunk T, Petrovski M, Batty KT. Physical compatibility of pentoxifylline and intravenous medications. Archives of disease in childhood. 2019;104(3):292-5. PUBMED LINK
Campbell AL, Petrovski M, Senarathna SG, Mukadam N, Strunk T, Batty KT. Compatibility of pentoxifylline and parenteral medications. Archives of disease in childhood. 2019. PUBMED LINK
Page-Sharp M, Strunk T, Salman S, Hibbert J, Patole SK, Manning L, et al. Simultaneous determination of pentoxifylline, metabolites M1 (lisofylline), M4 and M5, and caffeine in plasma and dried blood spots for pharmacokinetic studies in preterm infants and neonates. Journal of pharmaceutical and biomedical analysis. 2017;146:302-13. PUBMED LINK
Lauterbach R, Strunk T, Patole S, Hurkala J, Pawlik D. Compatibility of intravenous pentoxifylline with other medications infused concurrently in preterm infants with late-onset sepsis. Acta paediatrica 2018;107(7):1288-9. PUBMED LINK
Pammi M, Haque KN. Pentoxifylline for treatment of sepsis and necrotizing enterocolitis in neonates. Cochrane Database of Systematic Reviews. 2015(3). PUBMED LINK
For full texts of publications:
