Recruitment

Recruitment Status
Completed

Inclusion Criteria

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
Not capable of receiving enteral feedings prior to 7 days postnatally

Exclusion Criteria

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
...
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
Evidence of chronic white blood cell disease

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

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
Not capable of receiving enteral feedings prior to 7 days postnatally

Exclusion Criteria

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
...
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
Evidence of chronic white blood cell disease

Tracking Information

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