PROTECT Trial Information

Objective

To evaluate the effect of treatment with intravenous Pentoxifylline versus placebo, in infants born at less than 29 weeks gestation with late-onset sepsis (LOS) or necrotizing enterocolitis (NEC).

Study design

Multicentre 2-arm, randomised controlled trial.

Study population

Babies born less than 29 weeks gestation and greater than 72 hours old with suspected LOS or NEC.

Intervention

The two arms of the trial are:

i) Treatment group: intravenous pentoxifylline

ii) Control group: intravenous sodium chloride

Study intervention is administered during every episode of suspected LOS or NEC until discharge home or to a non-participating hospital.

Outcome measures

Primary outcome: survival without any disability at 24 months corrected age.

Secondary outcomes: i) survival until discharge home and at follow-up, ii) any disability at 24 months, iii) disability by grade and type, iv) progression from Stage II to Stage IIIA/B NEC, v) surgery for NEC, vi) duration of parenteral nutrition, vii) brain injury, viii) duration of mechanical ventilation, ix) chronic lung disease, x) time to full enteral feeds, xi) retinopathy of prematurity, xii) length of hospital stay.

Data/power analysis

900 infants with proven or probable LOS or proven NEC yield 80% power to detect a 25% reduction in risk of death or disability at 24 months, from 40% to 30%, with two-tailed alpha of 0.05.

Commencement date

October 2016

Investigators and contacts

Principal investigator: Professor Karen Simmer, AO, University of Western Australia

Project manager: Dr Alpana Ghadge

Project statistician: Dr Andrew Martin

Coordinating centre: NHMRC Clinical Trial Centre, Locked Bag 77, Camperdown NSW 1450

Telephone: +61-2-9562-5000

Fax: +61-2-9565-1863

Email: protect@ctc.usyd.edu.au

Australia New Zealand Clinical Trials Registry

(ANZCTR) Trial Registry Number: ACTRN12616000405415