Lactoferrin Prophylaxis in VLBW
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Ankara University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Ankara University
Information provided by:
Ankara University
ClinicalTrials.gov Identifier:
NCT01287507
First received: January 31, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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Purpose
The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin 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 Necrotizing Enterocolitis Infant, Very Low Birth Weight |
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 radiolgical findings.
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 ditension, vomitting 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
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2009 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287507
Contacts
| Contact: Ilke Mungan Akin | +90 5327072150 | ilkemungan@gmail.com |
Locations
| Turkey | |
| Ankara University School of Medicine Department of Pediatrics, NICU | Recruiting |
| Ankara, Turkey, 06500 | |
| Contact: Begum Atasay begumatasay@hotmail.com | |
| Principal Investigator: Ilke Mungan Akin | |
Sponsors and Collaborators
Ankara University
More Information
No publications provided
| Responsible Party: | Ankara University, Ankara University Department of Pediatrics Division of Neonatology |
| ClinicalTrials.gov Identifier: | NCT01287507 History of Changes |
| Other Study ID Numbers: | Lactoferrin |
| Study First Received: | January 31, 2011 |
| Last Updated: | January 31, 2011 |
| Health Authority: | Turkey: Ethics Committee |
Keywords provided by Ankara University:
|
VLBW, NEC, Late onset sepsis |
Additional relevant MeSH terms:
|
Birth Weight Enterocolitis Sepsis Toxemia Enterocolitis, Necrotizing Body Weight Signs and Symptoms Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013