Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Two Human Milk Fortifiers in Preterm Infants
Brief Summary: The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.


Options:
A: Inclusion criteria:

1. Gestational age \< 32weeks (maternal dates or early fetal ultrasound);
2. Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h;
3. Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥ 150 mL/kg/d) has been achieved; and
4. Written informed consent has been obtained from the infant's legal representative.

Exclusion criteria:

1. Infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight
2. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
3. Babies with enterostoma or short gut syndrome;
4. Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3);
5. Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/L79 and creatinine of 130 mmol/L80;
6. Hepatic dysfunction, defined by jaundice (direct bilirubin \>1.0 mg/dl) that is associated with one or more abnormal liver function tests (AST, ALT or GGT);
7. Participation in another clinical trial that may affect outcomes of this study; or
8. Probability of transfer to another NICU or level II nursery outside the McMaster Children's Hospital before the minimum period of three weeks is completed.

Post-randomisation exclusion criteria:

1. Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
2. Fluid restriction \< 140mL/kg/d for ≥ 3 consecutive days;
3. Sepsis - all infants with gram-negative sepsis will be removed from the study.
B: 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.
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:

* 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

Answer: B