Lactoferrin Prophylaxis in VLBW and Regulator T-cells

Not Applicable

Completed

• Conditions: Necrotising Enterocolitis; Very Low Birth Weight Infants; Late Onset Neonatal Sepsis
• Interventions: Dietary Supplement: Lactoferrin (bovine origin)

• Registration Number: NCT01287507
• Lead Sponsor: Ankara University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-01
• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-01
• Study Completion: 2011-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Congenital abnormalities
• Severe perinatal asphyxia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Lactoferrin (bovine origin)	In born VLBW infants with parental consent form signed will be given oral saline daily as placebo until discharge
Lactoferrin	Lactoferrin (bovine origin)	In born VLBW infants with parental consent form signed will be given oral bovine lactoferrin daily until discharge

Primary Outcome Measures

Name	Time	Method
Necrotising enterocolitis	from birth to discharge from NICU	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.
late onset sepsis	from birth to discharge from NICU	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.
Effect on T regulatory cells	at discharge	FOXP3 expression on CD4+CD25+ T cells

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ankara University School of Medicine Department of Pediatrics, NICU; 🇹🇷 Ankara, Turkey