Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Nosocomial Infections

In brief

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

Key facts

Study ID

NCT00854633

Run by

Agennix

People needed

120

Starts

2009-06-01

Expected to finish

2012-12-01

Last updated by the study team

2012-03-15

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Childrens Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• Kosair Children's Hospital — Louisville, Kentucky, United States (enrolling)
• University of Louisville Hospital — Louisville, Kentucky, United States (enrolling)
• University of Missouri Health Care, Columbia Regional Hospital — Columbia, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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