Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children
Brief Summary: Much has been learned in recent years about the mechanisms by which breastfeeding improves child health and survival. However, there has been little progress in using these insights to improve pediatric care. Factors that are important for protecting the breast fed infant might be expected to decrease the adverse effects of weaning on diarrhea, growth, and development. The proposed study is meant to begin addressing this important gap by a clinical trial of lactoferrin supplementation in previously weaned children. Lactoferrin,an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. Our hypothesis is that lactoferrin (given as a daily supplement in amounts similar to those consumed if the child were still breastfed) will improve health by mimicking its protective roles in milk. The significance of these studies is that they will prove feasibility of improving child health after the end of breastfeeding by continuing ingestion of a major protective milk protein. Diarrhea and malnutrition after weaning is a global problem that may be amenable to this approach.


Options:
A: 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
B: 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.
C: 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.
D: 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.

Answer: D