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Lactoferrin Prophylaxis in VLBW and Regulator T-cells

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ClinicalTrials.gov Identifier: NCT01287507
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
Ilke Mungan Akin, 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.

Condition or disease Intervention/treatment Phase
Late Onset Neonatal Sepsis Necrotising Enterocolitis Very Low Birth Weight Infants Dietary Supplement: Lactoferrin (bovine origin) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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.
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight Sepsis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. late onset sepsis [ Time Frame: 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.

  2. Necrotising enterocolitis [ Time Frame: 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.

  3. Effect on T regulatory cells [ Time Frame: at discharge ]
    FOXP3 expression on CD4+CD25+ T cells


Secondary Outcome Measures :
  1. Safety of lactoferrin in VLBW infants [ Time Frame: during the oral use of lactoferrin ]
    the effect oral lactoferrin use on feeding tolerance, abdominal distension, vomiting and gastric residuals

  2. duration of hospitalization [ Time Frame: from birth to discharge from neonatal intensive care unit ]
    the effect of oral lactoferrin on the duration of hospitalization



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ilke Mungan Akin, Neonatologist, Ankara University
ClinicalTrials.gov Identifier: NCT01287507     History of Changes
Other Study ID Numbers: Lactoferrin
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014

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

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