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Lactoferrin Prophylaxis in VLBW and Regulator T-cells

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ilke Mungan Akin, Ankara University
ClinicalTrials.gov Identifier:
NCT01287507
First received: January 31, 2011
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Late Onset Neonatal Sepsis
Necrotising Enterocolitis
Very Low Birth Weight Infants
Dietary Supplement: Lactoferrin (bovine origin)

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

Resource links provided by NLM:


Further study details as provided by Ankara University:

Primary Outcome Measures:
  • late onset sepsis [ Time Frame: from birth to discharge from NICU ] [ Designated as safety issue: No ]
    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.

  • Necrotising enterocolitis [ Time Frame: from birth to discharge from NICU ] [ Designated as safety issue: No ]
    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.

  • Effect on T regulatory cells [ Time Frame: at discharge ] [ Designated as safety issue: No ]
    FOXP3 expression on CD4+CD25+ T cells


Secondary Outcome Measures:
  • Safety of lactoferrin in VLBW infants [ Time Frame: during the oral use of lactoferrin ] [ Designated as safety issue: Yes ]
    the effect oral lactoferrin use on feeding tolerance, abdominal distension, vomiting and gastric residuals

  • duration of hospitalization [ Time Frame: from birth to discharge from neonatal intensive care unit ] [ Designated as safety issue: No ]
    the effect of oral lactoferrin on the duration of hospitalization


Enrollment: 60
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Congenital abnormalities
  • Severe perinatal asphyxia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287507

Locations
Turkey
Ankara University School of Medicine Department of Pediatrics, NICU
Ankara, Turkey, 06500
Sponsors and Collaborators
Ankara University
Investigators
Study Chair: Saadet Arsan, Prof Anlara University Chief of Neonatology
  More Information

No publications provided

Responsible Party: Ilke Mungan Akin, Neonatologist, Ankara University
ClinicalTrials.gov Identifier: NCT01287507     History of Changes
Other Study ID Numbers: Lactoferrin
Study First Received: January 31, 2011
Last Updated: August 25, 2014
Health Authority: Turkey: Ethics Committee

Keywords provided by Ankara University:
VLBW, NEC, Late onset sepsis

Additional relevant MeSH terms:
Birth Weight
Enterocolitis
Enterocolitis, Necrotizing
Sepsis
Body Weight
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Inflammation
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Systemic Inflammatory Response Syndrome
Lactoferrin
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014