Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2009 |
| End Date: | December 2012 |
| Contact: | Rajesh Malik, MD |
| Email: | rmalik@agennix.com |
| Phone: | 713-552-1091 |
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.
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
We found this trial at
4
sites
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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