Pentoxifylline in the Treatment of NEC in Premature Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Necrotizing Enterocolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type PLACEBO_COMPARATOR

Pentoxifylline

Intervention Type DRUG

B

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

Interventions

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Pentoxifylline

Intervention Type DRUG

Eligibility Criteria

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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)