NCT00854633

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2009

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

2.8 years

First QC Date

March 2, 2009

Last Update Submit

March 13, 2012

Conditions

Nosocomial Infections

Keywords

Pre-term infantsPre-term infants 750 to 1500 grams

Outcome Measures

Primary Outcomes (1)

  • Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)

    1-3 months

Secondary Outcomes (3)

  • "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

Study Arms (2)

1

EXPERIMENTAL

Talactoferrin

Drug: Talactoferrin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

TalactoferrinDRUG

Enteral, 150 mg/kg twice per day

Also known as: talactoferrin alfa, TLF, recombinant human lactoferrin, rhLF
1
PlaceboDRUG

Oral, twice per day

2

Eligibility Criteria

Age1 Minute - 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Childrens Hospital of Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

University of Missouri Health Care, Columbia Regional Hospital

Columbia, Missouri, 65201, United States

RECRUITING

Related Publications (2)

  • Sherman MP, Adamkin DH, Niklas V, Radmacher P, Sherman J, Wertheimer F, Petrak K. Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants. J Pediatr. 2016 Aug;175:68-73.e3. doi: 10.1016/j.jpeds.2016.04.084. Epub 2016 May 31.

    PMID: 27260839DERIVED

  • Sherman MP, Sherman J, Arcinue R, Niklas V. Randomized Control Trial of Human Recombinant Lactoferrin: A Substudy Reveals Effects on the Fecal Microbiome of Very Low Birth Weight Infants. J Pediatr. 2016 Jun;173 Suppl:S37-42. doi: 10.1016/j.jpeds.2016.02.074.

    PMID: 27234409DERIVED

MeSH Terms

Conditions

Cross Infection

Interventions

talactoferrin alfa

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Rajesh Malik, MD

CONTACT

713-552-1091rmalik@agennix.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(4)