NCT00271336

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 23, 2008

Status Verified

December 1, 2005

Enrollment Period

4.2 years

First QC Date

December 29, 2005

Last Update Submit

May 22, 2008

Conditions

Necrotizing Enterocolitis

Keywords

NECPremature InfantsTNFPentoxifylline

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

A

PLACEBO COMPARATOR
Drug: Pentoxifylline

B

EXPERIMENTAL
Drug: Pentoxifylline

Interventions

PentoxifyllineDRUG
AB

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Abdominal perforation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

RECRUITING

MeSH Terms

Conditions

Enterocolitis, NecrotizingPremature Birth

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Cathy Hammerman, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Hammerman, MD

CONTACT

9722 666-6238cathy@cc.huji.ac.il

Ruben Bromiker, MD

CONTACT

9722 666-6154bromi@szmc.org.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2005

First Posted

December 30, 2005

Study Start

January 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2010

Last Updated

May 23, 2008

Record last verified: 2005-12

Locations

IL(1)