ACTRN12616000405415.

Study name	Can pentoxifylline improve long‐term outcomes in preterm infants with late‐onset sepsis or necrotising enterocolitis? A pragmatic, randomised, placebo‐controlled trial
Methods	Randomised controlled trial
Participants	Preterm infants born at < 29 weeks' gestation
Interventions	Ideally within 6 hours (no later than 12 hours) of onset of suspected LOS or NEC, patient will receive pentoxifylline intravenous infusion 1 mL/kg/h for 12 hours/day (60 mg/kg/day) for 2 days. If the diagnosis of NEC or sepsis diagnosis is confirmed, this will be followed by 1 mL/kg/h for 6 hours/day (30 mg/kg/day) on days 3 to 6. If the diagnosis of NEC or LOS is not confirmed, the intervention will be discontinued at that time. Placebo is normal saline. Within 6 hours of onset of suspected LOS or NEC, patient will receive normal saline (NaCl 0.9%) intravenous infusion 1 mL/kg/h for 12 hours/day for 2 days. If the diagnosis of NEC or sepsis diagnosis is confirmed, this will be followed by 1 mL/kg/h for 6 hours/day (30 mg/kg/day) on days 3 to 6. If the diagnosis of NEC or LOS is not confirmed, the intervention will be discontinued at that time.
Outcomes	The primary outcome is survival without any disability at 24 months (corrected for gestation) in infants treated with intravenous pentoxifylline or placebo for LOS or NEC. Secondary outcomes are survival until discharge home and at 24 months (+/− 6 months), any disability at 24 months (+/− 6 months), disability by different grades and types will be assessed based on the BSID III and/or ASQ score and/or short health questionnaire administered to access cerebral palsy, deafness and blindness, composite secondary outcome looking at i) surgery for proven NEC and ii) progression of NEC stage II to stage IIIA/B as per Modified Bell's Staging Criteria for NEC, duration of parenteral nutrition, brain injury is defined as grade 3 and 4 intraventricular haemorrhage (on either side of the head), duration of mechanical ventilation in days, chronic lung disease, severe retinopathy of prematurity, length of hospital stay, plasma cytokine levels, magnetic resonance imaging at 38 to 42 weeks' corrected gestational age, and time to full enteral feeds.
Starting date	2016
Contact information	Prof Karen Simmer AO, email: karen.simmer@health.wa.gov.au
Notes	Currently recruiting, 597 of 1800 already recruited

ASQ: Ages & Stages Questionnaires; BSID: Bayley Scales of Infant Development; LOS: length of stay; NEC: necrotising enterocolitis