Will Lactoferrin supplements prevent infections in premature babies?

Phase 1

• Conditions: ate onset invasive infection in very preterm infants; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-004260-22-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-02
• Study Completion: 2018-05-03
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2203

Inclusion Criteria

Infants will be eligible to participate if:
• Gestational age at birth is less than 32 weeks
• Less than 72 hours old
• Written informed parental consent is obtained

If infants are receiving antibiotic treatment for suspected or confirmed infection, they are still eligible for recruitment.

Are the trial subjects under 18? yes
Number of subjects for this age range: 2200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Infants with a severe congenital anomaly
• Anticipated enteral fasting of more than 14 days
• Infants who, in the opinion of the treating clinician, have no realistic prospect of survival

Study & Design

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