- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00271336
Pentoxifylline in the Treatment of NEC in Premature Neonates
May 22, 2008 updated by: Shaare Zedek Medical Center
Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates
Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cathy Hammerman, MD
- Phone Number: 9722 666-6238
- Email: cathy@cc.huji.ac.il
Study Contact Backup
- Name: Ruben Bromiker, MD
- Phone Number: 9722 666-6154
- Email: bromi@szmc.org.il
Study Locations
-
-
-
Jerusalem, Israel, 91031
- Recruiting
- Shaare Zedek Medical Center
-
Principal Investigator:
- Cathy Hammerman, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B
|
|
Placebo Comparator: A
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Anticipated)
March 1, 2009
Study Completion (Anticipated)
March 1, 2010
Study Registration Dates
First Submitted
December 29, 2005
First Submitted That Met QC Criteria
December 29, 2005
First Posted (Estimate)
December 30, 2005
Study Record Updates
Last Update Posted (Estimate)
May 23, 2008
Last Update Submitted That Met QC Criteria
May 22, 2008
Last Verified
December 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Premature Birth
- Enterocolitis
- Enterocolitis, Necrotizing
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Protective Agents
- Antioxidants
- Phosphodiesterase Inhibitors
- Free Radical Scavengers
- Radiation-Protective Agents
- Pentoxifylline
Other Study ID Numbers
- chammerman1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Necrotizing Enterocolitis
-
Gorm GreisenCompletedComplications | NEC - Necrotizing EnterocolitisDenmark
-
Mednax Center for Research, Education, Quality...Phoenix Children's Hospital; Banner University Medical CenterCompletedTotal Parenteral Nutrition | Necrotizing Enterocolitis of NewbornUnited States
-
Ain Shams UniversityCompleted
-
Children's Hospital of PhiladelphiaBracco Diagnostics, IncRecruitingNecrotizing Enterocolitis of Newborn | Bowel IschemicUnited States
-
Medical University of WarsawNot yet recruitingNecrotizing EnterocolitisPoland
-
The University of Hong KongRecruitingNecrotizing EnterocolitisHong Kong
-
Marmara UniversityUnknownNecrotizing EnterocolitisTurkey
-
Maastricht University Medical CenterUnknown
-
Odense University HospitalCompletedNecrotizing EnterocolitisDenmark
-
Boston Children's HospitalYale University; Elizabeth Glaser Pediatric AIDS Foundation; Glaser Pediatric...Unknown
Clinical Trials on Pentoxifylline
-
Hospital Universitario de CanariasUnknown
-
Beijing Tiantan HospitalCSPC Ouyi Pharmaceutical Co., Ltd.Not yet recruitingCerebral Small Vessel DiseasesChina
-
Institute of Liver and Biliary Sciences, IndiaUnknown
-
Hospital Universitario de CanariasInstituto Médico Tinerfeño IMETISAUnknown
-
Assistance Publique - Hôpitaux de ParisMerck Sharp & Dohme LLCCompletedBenign Prostatic Hyperplasia (BPH) Requiring Surgical ResectionFrance
-
University of MichiganCompletedAcute Kidney FailureUnited States
-
Alexandria UniversityNot yet recruiting
-
National Cancer Institute (NCI)CompletedFibrosis | Radiation InjuriesUnited States
-
National Taiwan University HospitalCompletedPrimary GlomerulonephritisTaiwan