RecruitingPhase 3ACTRN12616000405415

Intravenous pentoxifylline as adjunct therapy to improve long-term disability in preterm infants

Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotising enterocolitis? A pragmatic, randomised, placebo-controlled trial

Sponsor

University of Sydney

Enrollment

1,800 participants

Start Date

Nov 21, 2016

Study Type

Interventional

Conditions

Late-onset sepsis (LOS)Preterm infants Necrotising enterocolitis (NEC)Long-term disability

Summary

Preterm infants are highly susceptible to bacterial late-onset sepsis (LOS) and necrotizing enterocolitis (NEC), both are major causes of systemic inflammation and contribute to brain injury and long-term disability in premature infants. Treating LOS and NEC are essential for survival, but suppressing systemic inflammation can also help reduce mortality, hospital stay and disability due to brain injury. The current treatments for NEC and LOS are limited to antibiotics, supportive care and surgery in some NEC cases, all of which do not aid in reducing systemic inflammation, therefore there is a need to reduce systemic inflammation. Pentoxifylline is a safe, low-cost, non-steroidal drug with potent immune-modulating activity with the potential of suppressing systemic inflammation induced by LOS or NEC. A recent Cochrane Review of 6 randomised controlled trials (RCT) suggests that PTX, given with antibiotics in neonatal sepsis, reduces mortality and length of hospital stay. We are conducting an international multicentre trial that will enrol and consent approximately 1,800 preterm infants (born <29 weeks gestational age). The primary aim is to evaluate the effect of treatment with intravenous Pentoxifylline versus placebo, starting within 6 hours from blood culture taken for suspected LOS or NEC. After 48 hours treatment will cease if diagnosis is refuted or will continue for 4 days if diagnosis is proven. The primary outcome to measure effectiveness is survival without disability at 18-24 months of age (corrected for gestation).

Eligibility

Sex: Both males and femalesMin Age: 72 HourssMax Age: 6 Monthss

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a medication called pentoxifylline can help very premature babies — those born before 29 weeks — survive without disability. When premature babies get a serious infection (called late-onset sepsis) or a bowel condition (called necrotising enterocolitis), their whole body can become dangerously inflamed. Pentoxifylline is a safe, inexpensive drug that may help calm this inflammation and reduce the risk of brain injury. This is a large international trial enrolling about 1,800 premature infants. You may be eligible if: - Your baby was born before 29 weeks of pregnancy - Your baby is being treated for suspected late-onset sepsis or necrotising enterocolitis - Enrolment happens within 6 hours of the blood culture being taken (and no later than 12 hours) - You as the parent are willing and able to provide informed consent You may NOT be eligible if: - Your baby has a congenital malformation, chromosomal abnormality, or another condition considered incompatible with surviving to 24 months without disability Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your Doctor Check Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Ideally within 6 hours (no later than 12 hours) of onset of suspected LOS or NEC patient will receive Pentoxifylline intravenous infusion 1ml/kg/h for 12h/day (60mg/kg/day) for 2 days. If the diagnosis of NEC or sepsis diagnosis is confirmed, this will be followed by 1ml/kg/h for 6hr/day (30mg/kg/day) on days 3-6. If the diagnosis of NEC or LOS is not confirmed the intervention will be discontinued at that time.