Risk of necrotizing enterocolitis (NEC) associated with a diet entirely of human milk. Digestive System Necrotizing enterocolitis
Conditions
Interventions
Premature infants receive an entirely human milk diet from birth through 33 weeks postmenstrual age
Sponsors
The Deaconess Women's Hospital (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All infants admitted to a single neonatal intensive care unit (NICU) from July 1, 2010 through December 31, 2012, and born before 33 weeks gestation
Exclusion criteria
Exclusion criteria: All infants admitted to the neonatal intensive care unit (NICU) in the study period are evaluated. Infants of parents that do not provide mother's own milk and also do not consent for donor human milk are excluded in the analysis of human milk-fed infants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of necrotizing enterocolitis (NEC) greater or equal to Bell's stage II. This is an event that has a dramatic onset. The onset is recorded in the EMR as a date. Retrospectively, the chronological day of onset (date of onset minus the date of birth) is determined. Similarly, the Postmenstrual Age (PMA) at onset (gestational age plus the chronological age) is also retrospectively determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed after completions includes: 1. Duration of parenteral nutrition (TPN): PN orders are written daily, beginning at the time of birth. PN is determined to stop on the day that no new parenteral orders are written. The duration is calculated retrospectively by PMA for the day PN stops: (gestational age plus the chronological age). 2. Duration of NICU hospitalization (postmenstrual age at discharge): The duration of hospital stay ends on the date the infant leaves the hospital and goes home with its parents. The duration is calculated retrospectively by PMA for the day the infant goes home: (gestational age plus the chronological age). 3. Markers of milk feeding intolerance: Enteral feeding tolerance is measured retrospectively, based on the feeding provided on the day the infant is discharged to the parents. Feeding categories include: breast milk; bovine based artificial milk with intact proteins; bovine based artificial milk with hydrolyzed proteins; amino-acid based artificial milk. (Intolerance of feeding occurs when bovine based artificial milk with hydrolyzed proteins or an amino-acid based artificial milk is prescribed on the day of discharge to the parents). Enteral feeding is measured retrospectively, determined by the use of a medication (metoclopramide), used at any duration of time for any reason prior to discharge to the parents. (Intolerance of feeding is suspected if metoclopramide is used on any day). | — |
Countries
United States of America
Outcome results
None listed