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Pentoxifylline in the Treatment of NEC in Premature Neonates

NCT ID: NCT00271336

Last Updated: 2008-05-23

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.

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

Keywords

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NEC Premature Infants TNF Pentoxifylline

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)

Exclusion Criteria

* Abdominal perforation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shaare Zedek Medical Center

Principal Investigators

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Cathy Hammerman, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Cathy Hammerman, MD

Role: CONTACT

Phone: 9722 666-6238

Email: [email protected]

Ruben Bromiker, MD

Role: CONTACT

Phone: 9722 666-6154

Email: [email protected]

Other Identifiers

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chammerman1

Identifier Type: -

Identifier Source: org_study_id