Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.

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