Lactoferrin Prophylaxis in VLBW and Regulator T-cells

Very Low Birth Weight Infants Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287507
• Other study ID #: Lactoferrin
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: August 25, 2014
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2014
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

Inclusion Criteria:

• Inborn infants

• Gestational age < 32 weeks

• Birth weight < 1500 g

• Parental consent

Exclusion Criteria:

• Congenital abnormalities

• Severe perinatal asphyxia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Enterocolitis
• Enterocolitis, Necrotizing
• Late Onset Neonatal Sepsis
• Necrotising Enterocolitis
• Sepsis
• Very Low Birth Weight Infants

Intervention

Dietary Supplement:
• Lactoferrin (bovine origin)
Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula

Locations

Country	Name	City	State
Turkey	Ankara University School of Medicine Department of Pediatrics, NICU	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Effect on T regulatory cells	FOXP3 expression on CD4+CD25+ T cells	at discharge	No
Secondary	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	Yes
Secondary	duration of hospitalization	the effect of oral lactoferrin on the duration of hospitalization	from birth to discharge from neonatal intensive care unit	No