Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-12-31

Brief Summary

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This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.

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Detailed Description

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Conditions

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Nosocomial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Talactoferrin

Group Type EXPERIMENTAL

Talactoferrin

Intervention Type DRUG

Enteral, 150 mg/kg twice per day

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral, twice per day

Interventions

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Talactoferrin

Enteral, 150 mg/kg twice per day

Intervention Type DRUG

Placebo

Oral, twice per day

Intervention Type DRUG

Other Intervention Names

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talactoferrin alfa TLF recombinant human lactoferrin rhLF

Eligibility Criteria

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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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No