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Pentoxifylline in the Treatment of NEC in Premature Neonates

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

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.

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.

Study Design

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

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00271336


Contacts
Contact: Cathy Hammerman, MD 9722 666-6238 cathy@cc.huji.ac.il
Contact: Ruben Bromiker, MD 9722 666-6154 bromi@szmc.org.il

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

Responsible Party: Cathy Hammerman, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00271336     History of Changes
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:
NEC
Premature Infants
TNF
Pentoxifylline

Additional relevant MeSH terms:
Premature Birth
Enterocolitis
Enterocolitis, Necrotizing
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pentoxifylline
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
Antioxidants