Pentoxifylline to improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis

Phase 1

• Conditions: ate onset sepsis & necrotising enterocolitis; MedDRA version: 20.1Level: LLTClassification code 10053598Term: Late onset neonatal sepsisSystem Organ Class: 100000004862; MedDRA version: 20.1Level: LLTClassification code 10028884Term: Necrotising enterocolitisSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-002548-26-IE
• Lead Sponsor: Royal College of Surgeons in Irlenad

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-11
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

1. Infants <29 weeks gestation within 6 hours of blood culture taken for suspected LOS or NEC
2. Signed, written informed consent by a parent or a legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range: 250
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Presence of major congenital malformation(s) or chromosomal abnormalities or any other conditions considered likely to be incompatible with disability-free survival

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified