Urinary Tract Infections in Children
Conditions
Keywords
urinary tract infections, infants, lactoferrin
Brief summary
The aim of the study was to evaluate the efficacy of orally administered bovine lactoferrin (bLF) on Urinary Tract Infections in neonates and infants. Fifty-five patients with urinary tract infection were randomized to receive either bLF (n = 27) or an identical placebo (n = 28) for 4 weeks. The patients were assessed clinically and laboratory.
Detailed description
This study was a prospective randomized controlled trial at a single university medical center. Participants were neonates or infants with Urinary Tract Infection (UTI) admitted to the Neonatal and Infant Pathology Department of Children's University Hospital in the period from July 2015 to December 2017. The intervention was bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks compared with placebo in a control group. During hospital treatment, laboratory tests were performed to evaluate the activity of inflammatory markers (C-reactive protein, procalcitonin, Interleukin-6 and Interleukin-8 levels and white blood cell count). Fifty-five patients heve been included in the study.
Interventions
DIETARY_SUPPLEMENTBovine Lactoferrin
Orally intake 1 sachet per day for 4 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution.
DIETARY_SUPPLEMENTplacebo
Orally intake 1 sachet per day for 4 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution.
Sponsors
Pharmabest Sp. z o.o.
Medical University of Lublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
patients with Urinary Tract Infections were recruited subjects were randomized into two groups: * the experimental group received bLF * the control group received placebo without bLF
Eligibility
Sex/Gender
ALL
Age
7 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
* Neonates and infants with symptoms of Urinary Tract Infection. * Active infection at enrollment, confirmed and documented in medical record. * Children with Urinary Tract Infection treated according to current recommendations.
Exclusion criteria
* Unconfirmed Urinary Tract Infection. * Critical illness and/or hemodynamic instability. * Allergy or sensitivity to lactoferrin or bovine derived proteins or bovine milk. * Children whose parents/guardians decline to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring of parameters of inflammation. | at baseline, after 5 days of treatment | C-reactive protein and procalcitonin levels in both groups. Comparing possible change. |
| Influence of lactoferrin on Interleukin-6 and Interleukin-8. | at baseline, after 5 days of treatment | Levels of Interleukin in both groups. Comparing possible change. |
| Effect of lactoferrin on white blood cells. | at baseline, after 5 days of treatment | To assess the change in the number of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils. |
| Effect of lactoferrin on urinary inflammatory markers. | at baseline, after 5 days of treatment | The presence of bacteria in urine and semi-quantitative measurement of white blood cells count in urine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of days of hospitalization. | 1 month | Length of stay. Comparing possible differences in groups. |
| Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects. | 1 month | Incidence, frequency and severity of treatment emergent adverse events. |
| To evaluate the efficacy of lactoferrin in the reduction of probable recurrence of Urinary Tract Infection. | 1 month | The number of recurrent Urinary Tract Infections occur due to bacterial reinfection or bacterial persistence. |
Outcome results
None listed