Neonatal necrotizing enterocolitis and motality
Conditions
Interventions
Group 2:Fresh Breast Milk
Group 1:previously frozen milk
Sponsors
Chinese Neonatal Network
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Born at <30 weeks gestation; 2. Who never received infant formula; 3. Admitted to one of the 28 participating tertiary NICUs in China; 4. Have parents who consent to the study; 5. Have mothers who are willing to providing at least 2 feeds of fresh milk a day, 7 days a week until the infant is 32 weeks corrected age.
Exclusion criteria
Exclusion criteria: 1. Infants with major congenital anomalies or receiving palliative care; 2. Infants with mothers who are too ill to provide fresh human milk in the first week after birth; 3. 1nfants with mothers who are unable to provide at least 2 feeds of fresh milk a day; 4. Infants with congenital Cytomegalic virus (CMV) infection; 5. Infants whose mothers have blood CMV-IgM (+), or CMV-DNA (+); 6. Infants with parents who are unwilling to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite of mortality or necrotizing enterocolitis = stage 2 before discharge; | — |
Secondary
| Measure | Time frame |
|---|---|
| mortality before discharge;NEC = stage 2;NEC needing surgery;late-onset sepsis;retinopathy of prematurity (ROP) and ROP requirement;bronchopulmonary dysplasia;change in weight, length, and head circumference;;time to full enteral feeds;number and type of critical incident reports, including feeding errors; | — |
Countries
Canada
Contacts
Public ContactShoo Lee
The Mount Sinai Hospital Affiliated to the University of Toronto
Outcome results
None listed