Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of a Novel Human Milk Fortifier in Preterm Infants
Brief Summary: The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.


Options:
A: Inclusion Criteria:

* Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
* Male or female
* Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
* Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
* Written informed consent has been obtained from the legal representative(s).

Exclusion Criteria:

* Infants with current systemic disease
* Infants with a history of systemic disease
* Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
* Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
* Infants diagnosed with any inherent metabolic disease.
* Infants diagnosed with any chromosomic disease.
* Receiving any commercial formula supplementation to breast milk.
* Receiving steroids at the time of enrollment.
* Participation in another nutritional clinical trial that may affect outcomes of this study.
B: 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
C: Inclusion Criteria:

* very preterm infants \<32 weeks gestation and \<1500g birth weight
* \> 100ml/kg/d of enteral feeding

Exclusion Criteria:

* missing informed consent
* decision not to feed breast milk
* congenital malformations
* age \> 7 days at study entry
D: 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

Answer: B