Lactoferrin Prophylaxis in VLBW and Regulator T-cells

NCT ID: NCT01287507

Last Updated: 2014-08-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.

Detailed Description

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Conditions

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Late Onset Neonatal Sepsis Necrotising Enterocolitis Very Low Birth Weight Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Placebo

In born VLBW infants with parental consent form signed will be given oral saline daily as placebo until discharge

Group Type PLACEBO_COMPARATOR

Lactoferrin (bovine origin)

Intervention Type DIETARY_SUPPLEMENT

Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula

Lactoferrin

In born VLBW infants with parental consent form signed will be given oral bovine lactoferrin daily until discharge

Group Type EXPERIMENTAL

Lactoferrin (bovine origin)

Intervention Type DIETARY_SUPPLEMENT

Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula

Interventions

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Lactoferrin (bovine origin)

Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Inborn infants
* Gestational age \< 32 weeks
* Birth weight \< 1500 g
* Parental consent

Exclusion Criteria

* Congenital abnormalities
* Severe perinatal asphyxia
Minimum Eligible Age

15 Minutes

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Ilke Mungan Akin

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saadet Arsan, Prof

Role: STUDY_CHAIR

Anlara University Chief of Neonatology

Locations

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Ankara University School of Medicine Department of Pediatrics, NICU

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Lactoferrin

Identifier Type: -

Identifier Source: org_study_id

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