This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Pentoxifylline in the Treatment of NEC in Premature Neonates

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Shaare Zedek Medical Center Identifier:
First received: December 29, 2005
Last updated: May 22, 2008
Last verified: December 2005
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
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

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 ]

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 ]

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.

Ages Eligible for Study:   Child, Adult, Senior
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
  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 identifier: NCT00271336

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

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

Responsible Party: Cathy Hammerman, Shaare Zedek Medical Center Identifier: NCT00271336     History of Changes
Other Study ID Numbers: chammerman1
Study First Received: December 29, 2005
Last Updated: May 22, 2008

Keywords provided by Shaare Zedek Medical Center:
Premature Infants

Additional relevant MeSH terms:
Premature Birth
Enterocolitis, Necrotizing
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
Antioxidants processed this record on September 20, 2017