Please select the eligibility criteria that correspond to the clinical trial below.
Title: ALFoNS - Growth and Metabolism in Infants Fed Protein-reduced, Alpha-lactalbumin Enriched Formula Compared to Breastfed Infants
Brief Summary: Formula composition is developed to resemble breast milk as close as possible, but there are still considerable differences between formula and breast milk composition, probably resulting in higher risk of overweight in childhood and higher incidence of infections in formula-fed infants. Protein levels are still higher and constituents such as alpha-lactalbumin lower in formula than in breast milk. By adding more alpha-lactalbumin to formula, rich in tryptophan, the resulting amino acid composition will allow further reduction of protein in formula. The investigators intend to include 320 infants, where 80 will be exclusively breastfed and the remainder assigned in a double blind, controlled, randomized manner to one of three formula groups; two experimental, protein reduced formula with two different levels of alpha-lactalbumin and one group given standard infant formula. The intervention period is from 4-8 weeks until 6 months of age. The infants will be followed by growth parameters, blood-, urine- and fecal biomarkers and health parameters until 5 years of age. The experimental formula will possibly result in growth, metabolism and gut microbiota as well as health parameters more similar to those of breastfed infants


Options:
A: Inclusion Criteria:

growing premature infants with a birth weight \< 2000g

Exclusion Criteria:

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation
B: Inclusion Criteria:

* Hospitalized preterm newborn infants, term infants and toddlers, and children and adolescents requiring parenteral nutrition (PN) for at least 5 consecutive days.
* Preterm infants were to require PN representing, at baseline, 80% of total estimated nutritional needs, and patients in the other groups (term infants toddlers; children) were to require PN representing, at baseline, at least 50% of total estimated nutritional needs.
* Patient whose parents or legally authorized representative had provided signed written informed consent

Exclusion Criteria:

* Patients with a life expectancy \< 6 days or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study were not included in the study.
* Patients with a diagnosis of shock, cardiac or renal failure with fluid overload, metabolic acidosis, respiratory failure, signs of sepsis, severe dyslipidemia, uncorrected metabolic disorders, severe sepsis, severe liver disease including cholestasis icterus, blood coagulation disorders and/or thrombophlebitis, acute myocardial infarction, or hypersensitivity to the active substance or any of the excipients of the test product, were not included in the study.
* Patients with specific nutritional requirements that could not be met by Ped3CB formulas were also excluded.
C: Inclusion Criteria:

* Gestational age \> 37 weeks
* Appropriate for gestational age (above 10th percentile,Lubchenko)
* Age of the mother at least 18 years
* Singleton pregnancies
* Residence in the study area
* Maternal command of the language

Exclusion Criteria:

* Gestational diabetes
* Major malformations (of the child) which might interfere with nutrition or growth
* Hormonal or metabolic diseases of the mother or the child, drug addiction during pregnancy
D: Inclusion

* Healthy infants
* Born vaginally (no caecerian section)
* 37+0 until 42+0
* Birth weight ± 2 SD of internationally approved growth charts
* No severe neonatal problems
* No feeding problems
* No evidence of systemic disease

Exclusion Criteria:

* Partial breast feeding at 8 weeks
* Breast feeding in the formula Group
* Formula feeding in the breast fed Group
* Caecerian section
* Treatment with antibiotics during the first 8 weeks

Answer: D