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Lactoferrin Prophylaxis in VLBW and Regulator T-cells

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lactoferrin (bovine origin)
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Late Onset Neonatal Sepsis focused on measuring VLBW, NEC, Late onset sepsis

Eligibility Criteria

15 Minutes - 1 Day (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Congenital abnormalities
  • Severe perinatal asphyxia

Sites / Locations

  • Ankara University School of Medicine Department of Pediatrics, NICU

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Lactoferrin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
Effect on T regulatory cells
FOXP3 expression on CD4+CD25+ T cells

Secondary Outcome Measures

Safety of lactoferrin in VLBW infants
the effect oral lactoferrin use on feeding tolerance, abdominal distension, vomiting and gastric residuals
duration of hospitalization
the effect of oral lactoferrin on the duration of hospitalization

Full Information

First Posted
January 31, 2011
Last Updated
August 25, 2014
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT01287507
Brief Title
Lactoferrin Prophylaxis in VLBW and Regulator T-cells
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Late Onset Neonatal Sepsis, Necrotising Enterocolitis, Very Low Birth Weight Infants
Keywords
VLBW, NEC, Late onset sepsis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In born VLBW infants with parental consent form signed will be given oral saline daily as placebo until discharge
Arm Title
Lactoferrin
Arm Type
Experimental
Arm Description
In born VLBW infants with parental consent form signed will be given oral bovine lactoferrin daily until discharge
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactoferrin (bovine origin)
Intervention Description
Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula
Primary Outcome Measure Information:
Title
late onset sepsis
Description
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.
Time Frame
from birth to discharge from NICU
Title
Necrotising enterocolitis
Description
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.
Time Frame
from birth to discharge from NICU
Title
Effect on T regulatory cells
Description
FOXP3 expression on CD4+CD25+ T cells
Time Frame
at discharge
Secondary Outcome Measure Information:
Title
Safety of lactoferrin in VLBW infants
Description
the effect oral lactoferrin use on feeding tolerance, abdominal distension, vomiting and gastric residuals
Time Frame
during the oral use of lactoferrin
Title
duration of hospitalization
Description
the effect of oral lactoferrin on the duration of hospitalization
Time Frame
from birth to discharge from neonatal intensive care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Minutes
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inborn infants Gestational age < 32 weeks Birth weight < 1500 g Parental consent Exclusion Criteria: Congenital abnormalities Severe perinatal asphyxia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saadet Arsan, Prof
Organizational Affiliation
Anlara University Chief of Neonatology
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara University School of Medicine Department of Pediatrics, NICU
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

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Lactoferrin Prophylaxis in VLBW and Regulator T-cells

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