ISRCTN88261002
Completed
Phase 3
A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants
niversity of Oxford (UK)0 sites2,200 target enrollmentJune 13, 2013
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Preterm infants, necrotising enterocolitis, late-onset invasive infection, lactoferrin
- Sponsor
- niversity of Oxford (UK)
- Enrollment
- 2200
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30574860 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30635141
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants will be eligible to participate if:
- •1\. Gestational age at birth is less than 32 weeks
- •2\. Less than 72 hours old
- •3\. Written informed parental consent is obtained
- •If infants are receiving antibiotic treatment for suspected or confirmed
- •Infection, they are still eligible for recruitment.
Exclusion Criteria
- •1\. Infants with severe congenital anomalies
- •2\. Anticipated enteral fasting of more than 14 days
- •3\. Infants who, in the opinion of the treating clinician, have no realistic prospect of survival
Outcomes
Primary Outcomes
Not specified
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