Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier
Brief Summary: It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.


Options:
A: Inclusion Criteria:

* Birth weight below 1,500 grams
* Written consent to participate from the parents

Exclusion Criteria:

* Congenital malformations
* Clinical syndromes known to affect growth and development
* Critical illness and short life expectancy
* If participants refuse to participate
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:

* Birth weight of 700 g-1500 g.
* ≤ 32 weeks and 0 days GA at birth.
* Appropriate for GA (AGA).
* Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0).
* Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified.
* Parent(s) agrees to allow infant to receive both human milk and HMF.
* Singleton or twin births only.

Exclusion Criteria:

* Enteral feeding of preterm infant formula or HMF for \> 7 days.
* Expected to be transferred to another facility and will not be able to be followed for at least 15 days.
* Serious congenital abnormalities or underlying disease that may affect growth and development.
* 5 minute APGAR ≤ 4.
* Steroids used at the time of randomization.
* Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).
* Mechanical ventilator dependence.
* Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.
* Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
* Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24).
* Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
* Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.
* Participation in another study that has not been approved as a concomitant study by AN.
D: 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.

Answer: D