Nosocomial Infections
Conditions
Keywords
Pre-term infants, Pre-term infants 750 to 1500 grams
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.
Interventions
DRUGTalactoferrin
Enteral, 150 mg/kg twice per day
DRUGPlacebo
Oral, twice per day
Sponsors
National Institutes of Health (NIH)
Agennix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 24 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP) | 1-3 months |
Secondary
| Measure | Time frame |
|---|---|
| NEC Scares, the Neonatal Sepsis Syndrome | 1-3 months |
| Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU | 1-3 months |
| Mortality during hospitalization | 1-3 months |
Countries
United States
Contacts
Primary ContactRajesh Malik, MD
Outcome results
None listed