Pentoxifylline as a secondary prophylaxis for necrotising enterocolitis in preterm neonates

Phase 2

Withdrawn

• Conditions: ecrotising enterocolitis; Necrotising enterocolitis; Reproductive Health and Childbirth - Complications of newborn; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12606000257561
• Lead Sponsor: KEM Hospital for Women, Perth

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

(1) Preterm neonates with at or greater than Stage II (definite) NEC will be eligible for enrolment as soon as the diagnosis is made and (2) Informed parental consent is obtained and (3) At least one cranial ultrasound has been performed prior to the diagnosis of NEC as routine surveillance for IVH or any other intracranial pathology.

Exclusion Criteria

(1) Failure to obtain informed parental consent (2) Presence of major congenital malformation/s (3) Presence of chromosomal aberrations (4) Presence of *hepatic impairment (Elevated serum aminotransaminase, alkaline phosphatase, and/or ammonia levels to >2.5 times the normal in presence of prolonged prothrombin and partial thromboplastin time) (5) Presence of *renal impairment (Blood urea nitrogen > 30 mg/dl, urine output <0.6 ml/kg/hour for at least 6 hours, and creatinine > 0.8 mg/dL) *Normal values (ALT: 3-54 U/L, AST: 10-65 U/L, Alkaline phosphatase: 110-400 U/L, Ammonia: 20-80 ?g/dL) and definitions of hepatic and renal impairment: Ref: Appendix A and D: 732-3 In Manual of Neonatal Care, Fifth Edition 2004, Eds: Cloherty JP, Eichenwald EC, Stark AR.

Study & Design

• Study Type: Interventional
• Study Design: Not specified