Preterm infants, necrotising enterocolitis, late-onset invasive infection, lactoferrin Digestive System Necrotising enterocolitis
Conditions
Interventions
Infants will be randomly allocated to receive either lactoferrin (150 mg/kg/day to a maximum
of 300 mg) or placebo. Until discharge they will be monitored for late-onset invasive infe
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of microbiologically-confirmed or clinically suspected late-onset infection from trial entry until hospital discharge. Clinicians will record whether or not infants have been treated for late-onset infection on the data collection form, however we are not recording specific test results. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality prior to hospital discharge 2. Necrotising enterocolitis (NEC): Bell's stage II or III 3. Severe retinopathy of prematurity (ROP) treated medically or surgically 4. Bronchopulmonary dysplasia (BPD): infant is still receiving mechanical ventilator support or supplemental oxygen at 36 weeks' postmenstrual age 5. A composite of invasive infection, major morbidity (NEC, ROP, or BPD as defined above) and mortality 6. Total number of days of administration of antibiotics per infant from 72 hours until death or discharge from hospital 7. Total number of days of administration of antifungal agents per infant 8. Total length of stay until discharge home 9. Length of stay in (i) intensive care, (ii) high dependency care, (iii) special care | — |
Countries
United Kingdom
Outcome results
None listed