Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00854633
Recruitment Status : Unknown
Verified March 2012 by Agennix.
Recruitment status was:  Recruiting
First Posted : March 3, 2009
Last Update Posted : March 15, 2012
National Institutes of Health (NIH)
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Nosocomial Infections Drug: Talactoferrin Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Study Start Date : June 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: 1
Drug: Talactoferrin
Enteral, 150 mg/kg twice per day
Other Names:
  • talactoferrin alfa
  • TLF
  • recombinant human lactoferrin
  • rhLF
Placebo Comparator: 2
Drug: Placebo
Oral, twice per day

Primary Outcome Measures :
  1. Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP) [ Time Frame: 1-3 months ]

Secondary Outcome Measures :
  1. "NEC Scares", the "Neonatal Sepsis Syndrome" [ Time Frame: 1-3 months ]
  2. Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU [ Time Frame: 1-3 months ]
  3. Mortality during hospitalization [ Time Frame: 1-3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00854633

Contact: Rajesh Malik, MD 713-552-1091

United States, California
Childrens Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
United States, Missouri
University of Missouri Health Care, Columbia Regional Hospital Recruiting
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
National Institutes of Health (NIH)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Agennix Identifier: NCT00854633     History of Changes
Other Study ID Numbers: LF-0901
1R44HD057744-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

Keywords provided by Agennix:
Pre-term infants
Pre-term infants 750 to 1500 grams

Additional relevant MeSH terms:
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Infective Agents