Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants
Sponsored by Baylor College of Medicine
About this trial
Last updated 5 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 5 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* Birth weight 500-1000 grams
* Reasonable expectation of survival for study duration (36 weeks postmenstrual age)
* Achieve any enteral feedings by 14 days of life
* Born at our institution or transferred from another institution within the first 24 hours of life and receive an exclusive human milk protein diet (mother's milk supplemented with donor human milk and donor human milk derived fortifier)
Exclusion Criteria
* Birth weight > 1000 grams
* Less than a reasonable expectation for survival for the study duration, enrolled in another clinical study that affects nutritional management
* Failure to achieve enteral feeds by 14 days of life
* Major congenital anomalies or clinically significant congenital heart disease, presence of intestinal perforation or Stage 2 NEC prior to tolerating fortified feeds
* Early transfer to a non-study institution
* Unable to participate in the study for any reason based on decision of study investigator
