Pentoxifylline in the Treatment of NEC in Premature Neonates

Shaare Zedek Medical Center

Status and phase: Unknown; Phase 2

Conditions: Necrotizing Enterocolitis

Treatments: Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT00271336

chammerman1

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Pentoxifylline

B

Experimental group

Treatment:

Drug: Pentoxifylline