Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Study of the Use of Human Milk Cream as a Caloric Supplement in a Subset of Very Low Birth Weight Pre-Term Infants
Brief Summary: Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.


Options:
A: Inclusion Criteria:

* Birth weight ≤ 1500g and gestational age \< 32weeks
* Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h

Exclusion Criteria:

* Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk
* gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities
* Babies with enterostoma or short gut syndrome
* Fluid restriction below
* Renal disease
* Sepsis
* Necrotizing enterocolitis
* Hepatic dysfunction
B: Inclusion Criteria:

* Birth weight 750 - 1250g
* Able to adhere to expected feeding protocol of mother's own milk/donor milk with fortification of Prolacta® fortifier
* Reasonable expectation of survival
* Enteral feeding must begin before the 21st day of life

Exclusion Criteria:

* Decision to not start minimum enteral feed before day 21 of life
* Unable to obtain informed consent from parent/guardian prior to the initiation of fortification of enteral feeding
* Enrolled in any other clinical study affecting nutritional management during the study period
* Presence of clinically significant congenital heart disease or major congenital malformations
* Reasonable potential for early transfer to a non-study institution
C: Inclusion Criteria:

* Premature infants born less than 32 weeks EGA
* Growth that is appropriate for gestational age (AGA)
* Admitted to OU Children's NICU, inborn or outborn
* Receiving enteral feedings \<100 mL/kg/day
* Hemodynamically stable

Exclusion Criteria:

* Severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings
* Growth restriction, growth that is small for gestational age (SGA) or large for gestational age (LGA)
* Inborn errors of metabolism
* History of necrotizing enterocolitis Bell stage III
* Cerebrospinal fluid indwelling shunt (affects body composition measurements)
* Expected death prior to 36 weeks EGA (the end of the study period)
* Inability to meet Pea Pod® requirements for the first measurement
* On vasopressor medications
D: Inclusion Criteria:

* 700-1500g birth weight
* 33 weeks or less gestational age
* Appropriate for gestational age
* Initiate enteral feeds of human milk by 21 days of life
* Mother provided exclusive human milk feeds
* Parents allow both human milk and study human milk fortifier
* Singleton or twin birth

Exclusion Criteria:

* Feeding preterm infant formula or non-study human milk fortifier
* Expected at facility less than 15 days
* Congenital anomalies/disease affecting growth and development
* 5 minute APGAR of 4 or less
* Steroid use
* ECMO
* Grade III or IV PVH/IVH
* Mechanical ventilator dependency
* Maternal incapacity
* History of major surgery
* Asphyxia
* Confirmed NEC or sepsis
* Use of probiotics

Answer: B