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The PROTECT study will evaluate the effect of pentoxifylline for preterm babies with late-onset sepsis or necrotizing enterocolitis. The study aims to see if pentoxifylline improves survival without disability in these babies.
See ANZCTR for full trial details >
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Why participate? |
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Trial Summary: |
Late-onset sepsis (LOS) and necrotizing enterocolitis (NEC) are the principal causes of systemic inflammation in preterm infants and contribute significantly to brain injury and long-term disability. While antimicrobial therapy effectively reduces bacterial load, it does not neutralise highly potent bacterial ligands and induced inflammatory mediators. This study will evaluate the effect of treatment with intravenous pentoxifylline versus placebo, in infants born at less than 29 weeks gestation who have LOS or NEC to see if survival and/or disability is improved. |
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Supported By: |
NHMRC |
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Eligibility: |
Infants born less than 29 weeks gestation. |
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Registration ID: |
ACTRN12616000405415 |
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Participation: |
A target of 1,800 babies born less than 29 weeks gestation with suspected sepsis or necrotizing enterocolitis. 900 infants with confirmed or clinical sepsis and proven NEC. |
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Australian Lead Group: |
NHMRC CTC |
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Status: |
Recruiting |
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Activation Date: |
22/09/2016 |
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Chairs: |
Prof Tobias Strunk (Chair) |
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Contact: |