Pentoxifylline in the Treatment of NEC in Premature Neonates

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Pentoxifylline

About this trial

This is an interventional treatment trial for Necrotizing Enterocolitis focused on measuring NEC, Premature Infants, TNF, Pentoxifylline

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Shaare Zedek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome 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.

Secondary Outcome 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.

Full Information

NCT ID

NCT00271336

First Posted

December 29, 2005

Last Updated

May 22, 2008

Sponsor

Shaare Zedek Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00271336

Brief Title

Pentoxifylline in the Treatment of NEC in Premature Neonates

Official Title

Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates

Study Type

Interventional

2. Study Status

Record Verification Date

December 2005

Overall Recruitment Status

Unknown status

Study Start Date

January 2005 (undefined)

Primary Completion Date

March 2009 (Anticipated)

Study Completion Date

March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Necrotizing Enterocolitis

Keywords

NEC, Premature Infants, TNF, Pentoxifylline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Placebo Comparator

Arm Title

B

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Pentoxifylline

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cathy Hammerman, MD

Phone

9722 666-6238

Email

cathy@cc.huji.ac.il

First Name & Middle Initial & Last Name or Official Title & Degree

Ruben Bromiker, MD

Phone

9722 666-6154

Email

bromi@szmc.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cathy Hammerman, MD

Organizational Affiliation

Shaare Zedek Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cathy Hammerman, MD

Necrotizing Enterocolitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial