Lactoferrin Prophylaxis in VLBW and Regulator T-cells

Ankara University

Status: Completed

Conditions: Very Low Birth Weight Infants; Necrotising Enterocolitis; Late Onset Neonatal Sepsis

Treatments: Dietary Supplement: Lactoferrin (bovine origin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01287507

Lactoferrin

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 15 minutes to 1 day old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Congenital abnormalities
• Severe perinatal asphyxia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Lactoferrin (bovine origin)

Lactoferrin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactoferrin (bovine origin)