Lactoferrin Prophylaxis in VLBW and Regulator T-cells

NCT01287507 | Completed

• 1 other identifier: Lactoferrin
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Late Onset Neonatal Sepsis; Necrotising Enterocolitis; Very Low Birth Weight Infants

Keywords

VLBW, NEC, Late onset sepsis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Safety of lactoferrin in VLBW infants

  during the oral use of lactoferrin

• duration of hospitalization

  from birth to discharge from neonatal intensive care unit

Study Arms (2)

Placebo

PLACEBO COMPARATOR

In born VLBW infants with parental consent form signed will be given oral saline daily as placebo until discharge

Dietary Supplement: Lactoferrin (bovine origin)

Lactoferrin

EXPERIMENTAL

In born VLBW infants with parental consent form signed will be given oral bovine lactoferrin daily until discharge

Dietary Supplement: Lactoferrin (bovine origin)

Interventions

Lactoferrin (bovine origin) DIETARY_SUPPLEMENT

Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula

Lactoferrin; Placebo

Eligibility Criteria

• Age: 15 Minutes - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Congenital abnormalities
• Severe perinatal asphyxia

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University School of Medicine Department of Pediatrics, NICU

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neonatal Sepsis; Enterocolitis, Necrotizing

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Saadet Arsan, Prof

  Anlara University Chief of Neonatology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 1, 2011
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

TU (1)