Pentoxifylline in the Treatment of NEC in Premature Neonates

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00271336
Study type	Interventional
Source	Shaare Zedek Medical Center
Contact	Cathy Hammerman, MD
Phone	9722 666-6238
Email	cathy@cc.huji.ac.il
Status	Recruiting
Phase	Phase 2
Start date	January 2005
Completion date	March 2010

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05544097` - Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis	N/A
Recruiting	`NCT03210831` - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Recruiting	`NCT02552706` - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis	N/A
Completed	`NCT02400697` - Placental Transfusion Project for Preterm Infants	N/A
Completed	`NCT01751477` - Infloran® for Prevention of Necrotizing Enterocolitis	N/A
Terminated	`NCT01156480` - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants	N/A
Completed	`NCT00787124` - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status	`NCT00254176` - Cysteine Supplementation in Critically Ill Neonates	Phase 2/Phase 3
Recruiting	`NCT01441739` - Intestinal Failure in Necrotising Enterocolitis	N/A
Recruiting	`NCT04074824` - A Genome-Wide Association Study for Neonatal Diseases
Recruiting	`NCT03869827` - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Terminated	`NCT03320785` - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting	`NCT03554278` - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting	`NCT04541771` - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants	Phase 2
Not yet recruiting	`NCT03700957` - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates	N/A
Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed	`NCT01745510` - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates	Phase 1/Phase 2
Completed	`NCT01735578` - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis	N/A
Unknown status	`NCT01807858` - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants	N/A