Trial of lactoferrin for prevention of infections in very premature babies

Not Applicable

Completed

Conditions: Healthcare-associated infections in preterm infants
Pregnancy and Childbirth
Extreme immaturity

Registration Number: ISRCTN66482337

Lead Sponsor: Research Center of CHU Sainte-Justine [Centre de Recherche de CHU Sainte-Justine] (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

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

Intestinal abnormailities preventing enteral feeding, such as gastroschisis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Death or at least one HCAI before discharge home<br>2. Tolerance of lactoferrin

Secondary Outcome Measures

Name	Time	Method
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. <br>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.<br>3. Surgical intervention for NEC, or spontaneous intestinal perforation will be recorded<br>4. Death ascribed to acute effects of sepsis