Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Brief Summary: This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.


Options:
A: Inclusion Criteria:

1. Infants 12 to 18 months of age from the Outpatient clinics (Puestos de Salud) of Districto de Independencia in Lima, Peru will be eligible for enrollment in this study.
2. Infants previously weaned for at least one week will be eligible for study.

Exclusion Criteria:

1. Infants with either exclusive or partial breast-feeding will not be enrolled; mothers will be encouraged to continue breastfeeding.
2. Infants ill with severe, persistent or chronic diarrhea will be excluded.
3. Infants with severe malnutrition (defined as weight-for-height \< -3 SDs, height-for-age \< -3SDs)will be excluded.
4. Infants with a serious infections that required hospitalization 1 month prior (e.g. meningitis,pneumonia, bacteremia) will be excluded.
5. Infants with known HIV (data from parent or medical records) will be excluded.
6. Infants with underlying chronic illness (e.g. malignancy, immunosuppression, chronic renal failure, congestive heart failure, liver failure) will be excluded.
7. Infants with history of allergy to cow's milk or infant formula, eczema, allergic rhinitis or asthma will be excluded.
8. Infants with a family history of eczema, allergic rhinitis, asthma, or milk intolerance will be excluded.
B: Inclusion Criteria:

* Neonates with a birth weight between 500g and 2000g
* Neonates born in, or referred to the Neonatal Intermediate and Intensive Care Units of one of the participating hospitals in the first 72 hours of life.

Exclusion Criteria:

* Neonates with underlying gastrointestinal problems that prevent oral intake.
* Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
* Neonates who have a family history of cow milk allergy.
* Neonates that, according to the investigator criteria, will not have the chance to complete the subsequent study visits (patients that before one month old would not be living in Lima).
* Neonates whose parents decline to participate.
C: Inclusion Criteria:

1. Neonates with a birth weight between 500g and 2500g
2. Neonates born in, or referred to the Neonatal Intermediate and Intensive Care Units of one of the participating hospitals in the first 72 hours of life.

Exclusion Criteria:

1. Neonates with underlying gastrointestinal problems that prevent oral intake.
2. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities)
3. Neonates with a family background of cow milk allergy
4. Neonates that, according to the investigator criteria, will not have the chance to complete the subsequent study visits (patients that before one month old would not be living in Lima).
5. Neonates whose parents decline to participate.
D: Inclusion Criteria:

* Birth weights ranging from 750 to 1500 grams
* Entry before 24 hours of age
* Informed-consent form signed by parent(s) or legal guardian
* Able to take liquid medication by mouth or feeding tube

Exclusion Criteria

* A major birth defect or malformation syndrome
* Chromosomal or inherited disorder
* Proven presence of an immunodeficiency
* Antenatal exposure to illicit substances
* Birth asphyxia
* HIV or other congenital viral, bacterial, or fungal infection
* Lack of parental consent or refusal of attending neonatologist to allow participation
* Discretion of the investigator
* The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support

Answer: D