Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agennix
• Collaborator: National Institutes of Health (NIH)
• Treatments: Lactoferrin; Talactoferrin alfa

Criteria

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