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Pentoxifylline in the Treatment of NEC in Premature Neonates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00271336
First received: December 29, 2005
Last updated: May 22, 2008
Last verified: December 2005
  Purpose

Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates.


Condition Intervention Phase
Necrotizing Enterocolitis
Drug: Pentoxifylline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

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. [ Time Frame: Three years ] [ Designated as safety issue: No ]

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. [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2005
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Pentoxifylline
Experimental: B Drug: Pentoxifylline

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.

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cathy Hammerman, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00271336     History of Changes
Other Study ID Numbers: chammerman1
Study First Received: December 29, 2005
Last Updated: May 22, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
NEC
Premature Infants
TNF
Pentoxifylline

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Pentoxifylline
Antioxidants
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014