Very Low Birth Weight Infants Clinical Trial
Official title:
Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.
Status | Completed |
Enrollment | 300 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 6 Months |
Eligibility |
Inclusion Criteria: - Very low birth weight infants < 1500 gr - Gestational age < 32 weeks Exclusion Criteria: - Genetic anomalies - Short bowel syndrome - Not willing to participate - Allergy to Lactobacillus reuteri components |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Turkey | Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology | Ankara |
Lead Sponsor | Collaborator |
---|---|
Zekai Tahir Burak Women's Health Research and Education Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants | Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly. | up to 6 months | Yes |
Secondary | Effect of Lactobacillus reuteri on feeding intolerance | Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools) | up to 6 months | Yes |
Secondary | Effect of Lactobacillus reuteri on sepsis | Patients with culture positivity will accept as proven sepsis. | up to 6 months | Yes |
Secondary | Effect of Lactobacillus reuteri on length of hospital stay | Specified length of hospital stay as days. | up to 6 months | Yes |
Secondary | Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants | NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group. | up to 6 months | No |
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