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Pentoxifylline in the Treatment of NEC in Premature Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00271336
Recruitment Status : Unknown
Verified December 2005 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : December 30, 2005
Last Update Posted : May 23, 2008
Information provided by:
Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Necrotizing Enterocolitis Drug: Pentoxifylline Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates
Study Start Date : January 2005
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: A Drug: Pentoxifylline
Experimental: B Drug: Pentoxifylline

Primary Outcome Measures :
  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. [ Time Frame: Three years ]

Secondary Outcome Measures :
  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. [ Time Frame: Three years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00271336

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Contact: Cathy Hammerman, MD 9722 666-6238
Contact: Ruben Bromiker, MD 9722 666-6154

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Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Principal Investigator: Cathy Hammerman, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center

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Responsible Party: Cathy Hammerman, Shaare Zedek Medical Center Identifier: NCT00271336    
Other Study ID Numbers: chammerman1
First Posted: December 30, 2005    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: December 2005
Keywords provided by Shaare Zedek Medical Center:
Premature Infants
Additional relevant MeSH terms:
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Enterocolitis, Necrotizing
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers