Recruitment

Recruitment Status
Completed

Inclusion Criteria

Not capable of receiving enteral feedings prior to 7 days postnatally
Weight less than 1500 g at birth
Not capable of receiving enteral feedings prior to 7 days postnatally
Weight less than 1500 g at birth

Exclusion Criteria

Evidence of chronic white blood cell disease
Current viral infections
Presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease
...
Evidence of chronic white blood cell disease
Current viral infections
Presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease
Enterocolitis confirmed by diagnosis
Metabolic abnormalities such as inborn errors of metabolism

Summary

Conditions
Preterm Infants
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Inclusion Criteria

Not capable of receiving enteral feedings prior to 7 days postnatally
Weight less than 1500 g at birth
Not capable of receiving enteral feedings prior to 7 days postnatally
Weight less than 1500 g at birth

Exclusion Criteria

Evidence of chronic white blood cell disease
Current viral infections
Presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease
...
Evidence of chronic white blood cell disease
Current viral infections
Presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease
Enterocolitis confirmed by diagnosis
Metabolic abnormalities such as inborn errors of metabolism

Locations

Portland, Oregon, 97227
Portland, Oregon, 97227

Tracking Information

NCT #
NCT02066610
Collaborators
Not Provided
Investigators
Study Chair: Marlene Borschel, Ph.D Abbott Nutrition