Status:
UNKNOWN
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Lead Sponsor:
Agennix
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Nosocomial Infections
Eligibility:
All Genders
1-24 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00854633
Start Date
June 1 2009
End Date
December 1 2012
Last Update
March 15 2012
Active Locations (4)
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1
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
3
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
4
University of Missouri Health Care, Columbia Regional Hospital
Columbia, Missouri, United States, 65201