Pentoxifylline in the Treatment of NEC in Premature Neonates

Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00271336

Enrollment

Registered

2005-12-30

Start date

2005-01-31

Completion date

2010-03-31

Last updated

2008-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis

Keywords

NEC, Premature Infants, TNF, Pentoxifylline

Brief summary

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

Detailed description

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.

Interventions

DRUGPentoxifylline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	Three years

Secondary

Measure	Time frame
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.	Three years

Countries

Israel

Contacts

Primary ContactCathy Hammerman, MD

cathy@cc.huji.ac.il9722 666-6238

Backup ContactRuben Bromiker, MD

bromi@szmc.org.il9722 666-6154

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026