Official Title: “Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates”

Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2009

Preterm neonates with a clinical suspicion of necrotizing enterocolitis (NEC) will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1. Treatment group: to receive IV pentoxifylline (5 mg/kg/hour to run over 6 hour x 6 days) and 2. Placebo group: to receive an equal volume of ½ normal saline to run over 6 hours x 6 days.

Intervention(s) in this Clinical Trial

• Drug: Pentoxifylline

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
• Experimental: B

Primary Measures

• To demonstrate that fewer of the babies who are treated with PTX will progress to serious NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement], and/or death related to NEC.
  • Time Frame: Three years
    Safety Issue?: No

Secondary Measures

• To demonstrate lower levels of TNF alpha,fecal calprotectin;Improved SMA blood flow;Quicker radiographic resolution; Decreased feeding intolerance after acute NEC episode; and lower NEC associated long term morbidity.
  • Time Frame: Three years
    Safety Issue?: No

Inclusion Criteria:

• Preterm infants <1750 gm. birth weight
• Abdominal x-ray consistent with NEC (dilated loops, bowel wall edema, fixed or persistent dilated loop with (or without pneumatosis)

Exclusion Criteria:

• Abdominal perforation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shaare Zedek Medical Center

Overall Clinical Trial Officials and Contacts

Cathy Hammerman, MD Principal Investigator Shaare Zedek Medical Center  

Overall Contact: Cathy Hammerman, MD 9722 666-6238 cathy@cc.huji.ac.il

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00271336

Study ID Number: chammerman1

ClinicalTrials.gov Identifier: NCT00271336

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration