Lactoferrin Prophylaxis in VLBW and Regulator T-cells

Oral Lactoferrin Prophylaxis to Prevent Sepsis and Necrotising Enterocolitis of Very Low Birth Weight Neonates in Neonatal Intensive Care Unit and Effect on T-regulatory Cells.

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.

Study Overview

• Status: Completed
• Conditions: Very Low Birth Weight Infants; Necrotising Enterocolitis; Late Onset Neonatal Sepsis
• Intervention / Treatment: Dietary supplement: Lactoferrin (bovine origin)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06500
    • Ankara University School of Medicine Department of Pediatrics, NICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 minutes to 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Congenital abnormalities
• Severe perinatal asphyxia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; In born VLBW infants with parental consent form signed will be given oral saline daily as placebo until discharge	Dietary supplement: Lactoferrin (bovine origin); Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula
Experimental: Lactoferrin; In born VLBW infants with parental consent form signed will be given oral bovine lactoferrin daily until discharge	Dietary supplement: Lactoferrin (bovine origin); Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late onset sepsis	The effect of oral Lactoferrin prophylaxis on the number of culture proven sepsis attacks in very low birth weight infants during their hospitalization in neonatal intensive care unit. Sterile blood, urine and cerebrospinal fluid samples will be obtained in case of clinical symptoms of sepsis for culture.	from birth to discharge from NICU
Necrotising enterocolitis	The effect of oral Lactoferrin prophylaxis on severe necrotising enterocolitis (NEC) (Bell's stage 2 and 3) in very low birth infants during the hospitalization period in Neonatal intensive care unit. In case of feeding intolerance, abdominal distention and findings of ileus with clinical deterioration, patient will be evaluated for thrombocytopenia, metabolic acidosis, hyponatremia, blood in stool and radiological findings of NEC. Staging will be performed with clinical, laboratory and radiological findings.	from birth to discharge from NICU
Effect on T regulatory cells	FOXP3 expression on CD4+CD25+ T cells	at discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of lactoferrin in VLBW infants	the effect oral lactoferrin use on feeding tolerance, abdominal distension, vomiting and gastric residuals	during the oral use of lactoferrin
duration of hospitalization	the effect of oral lactoferrin on the duration of hospitalization	from birth to discharge from neonatal intensive care unit

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Study Chair: Saadet Arsan, Prof, Anlara University Chief of Neonatology

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: January 31, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Estimate): August 26, 2014
• Last Update Submitted That Met QC Criteria: August 25, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: VLBW, NEC, Late onset sepsis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Gastrointestinal Diseases; Infant, Newborn, Diseases; Body Weight; Gastroenteritis; Intestinal Diseases; Sepsis; Birth Weight; Enterocolitis; Enterocolitis, Necrotizing; Neonatal Sepsis; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: Lactoferrin