Healthcare-associated infections in preterm infants Pregnancy and Childbirth Extreme immaturity
Conditions
Interventions
Infants allocated to the treatment group will receive 100 mg per day of bovine lactoferrin, divided into two doses per day. This will start on the first day of enteral feeding (day of enrolment) or at
Sponsors
Research Center of CHU Sainte-Justine [Centre de Recherche de CHU Sainte-Justine] (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Preterm infants in the neonatal intensive care unit (NICU) at CHU Sainte Justine, with a gestational age at birth of 23 0/7 to 30 6/7 weeks who are less than 48 hours of age
Exclusion criteria
Exclusion criteria: Intestinal abnormailities preventing enteral feeding, such as gastroschisis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Death or at least one HCAI before discharge home 2. Tolerance of lactoferrin | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Infections per 1000 patient days. Because some infants may experience more than one HCAI during their stay, and others may be transported to level 2 step-down units prior to discharge home, other analyses of infection rates are required. Calculation of the number of infections per 1000 patient days corrects for some of these factors. 2. Necrotizing Enterocolitis (NEC): The diagnostic criteria for NEC which will be used as the primary outcome will be the modified Bell?s criteria, stage 2 or more, i.e. a clinical diagnosis of necrotizing enterocolitis with, in addition pneumatosis intestinalis or portal venous gas, or a surgical or autopsy diagnosis of NEC. 3. Surgical intervention for NEC, or spontaneous intestinal perforation will be recorded 4. Death ascribed to acute effects of sepsis | — |
Countries
Canada
Outcome results
None listed