Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of Gluconeogenesis in Very Low Birth Weight Infants Receiving Total Parenteral Nutrition
Brief Summary: RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known.

PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.


Options:
A: Inclusion Criteria:

* Singleton, 1-7 days of age at registration or randomization
* Term infant with appropriate birth weight for gestational age
* Either solely formula fed or exclusively receiving mother's own breast milk
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Caesarean delivery
* Infant was born from a mother with Type 1 diabetes
* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or history of formula or human milk intolerance
* Signs of acute infection of current use of antibiotics
B: * Clinically stable, very low birth weight infants (750-1,500 grams)
* Normal blood glucose values OR Blood glucose greater than 175 mg/dL
* No prior insulin
* No sepsis Oxygen supply less than 30% Normal acid base status
* No malformation
* No discernible diseases
C: Inclusion Criteria:

* Infants ≤ 8 months of age
* Infants sensitised to cow's milk and diagnosed with IgE mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months

Exclusion Criteria:

* Infants less than 2500 g at birth
* Infants less than 37 weeks gestation
* Infants with severe concurrent illness
* Use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs
* Infants consuming less than 500ml per day of their usual formula at study entry
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
D: 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.

Answer: B