Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight (ELBW) Infants
Brief Summary: This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.


Options:
A: Inclusion Criteria:

1. Infants expected to need prolonged PN (receiving \>75% PN on dol 7) with the following risk factors:

   1. Prematurity with gestational age (GA) \<32 weeks AND birth weight \<1500g. OR
   2. Congenital anomaly of the gastrointestinal tract regardless of GA or BW
2. Screening direct bilirubin prior to the initiation of parenteral nutrition \<2mg/dL.

Exclusion Criteria:

1. Infants with major congenital anomalies, other than those of the gastrointestinal tract.
2. Infants with known obstruction of the hepatobiliary tract.
3. Infants with suspected congenital infection or suspected genetic/metabolic syndrome predisposing them to cholestasis based on direct bilirubin \> 2mg/dL prior to instituting PN.
B: Inclusion Criteria:

* Less than or equal to 6 months of age
* 36-42 weeks gestational age at birth
* Singleton or Twin birth
* Diagnosed with protein sensitive colitis
* Negative stool culture at time of study entry
* No previous history of consuming free amino acid-based medical food
* Not receiving cisapride or steroids
* No vitamin mineral supplement administration during the study period with the exception of iron or fluoride
* No milk or soy products for the duration of the study
C: Inclusion Criteria:

* Born at term (\>36 weeks gestation)
* 2 months to ≤12 years of age at enrollment
* Documented CMA within 6 months prior to enrollment
* Otherwise healthy
* Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
* Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
* Having obtained his/her legal representative's informed consent

Exclusion:

* Children consuming mother's milk at the time of inclusion and during the trial
* Any chromosomal or major congenital anomalies
* Any major gastrointestinal disease or abnormalities other than CMA
* Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)
* Immunodeficiency
* Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
* Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
* Unstable asthma
* Severe uncontrolled eczema
* Severe anaphylactic reaction to milk within the last 2 years
* Severe anaphylactic reaction to breastmilk within the last 2 years
* Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
* Currently participating in another clinical trial.
D: Inclusion Criteria:

* 401-1000 gm
* More than 12 hrs and less than 72 hrs after birth; intravenous access
* Parental consent

Exclusion Criteria:

* One or more major congenital anomalies
* Infants meeting criteria for terminal illness
* Congenital nonbacterial infection with overt signs at birth

Answer: D