Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Phase 1

• Conditions: Nosocomial Infections
• Interventions: Drug: Talactoferrin; Drug: Placebo

• Registration Number: NCT00854633
• Lead Sponsor: Agennix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Study Start: 2009-06
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-15
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Talactoferrin	Talactoferrin
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)	1-3 months

Secondary Outcome Measures

Name	Time	Method
"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

Trial Locations

Locations (4)

Childrens Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

University of Missouri Health Care, Columbia Regional Hospital; 🇺🇸 Columbia, Missouri, United States

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States

Kosair Children's Hospital; 🇺🇸 Louisville, Kentucky, United States