Zinc in Pediatric Sepsis
Conditions
Brief summary
a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit.
Detailed description
a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit. The study included 72 cases that were randomly divided into 2 groups A- Group A (Zinc treated group): Included 36 cases who received oral zinc sulfate supplementation at doses ranging from 10 mg (infants) to 20 mg (under-five children) of elemental zinc per day, a dosage that is safe in these children. B- Group B: Included 36 cases who didn't receive zinc sulfate supplementation. Method of randomization: The cases were randomly divided into two groups using the closed envelope technique. The numbers from 1 to 72 were written in flat pieces of papers and put in closed envelopes that were randomly distributed to the participants. The cases with the odds number were allocated to the zinc treated group while the cases with the even numbers were allocated to the other group.
Interventions
DRUGoral zinc sulfate
Oral zinc sulfate at dose 10 to 20 mg daily for 10 days
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* 2- Pediatric patients who fulfill Pediatric Consensus criteria for definition of severe sepsis as 1) greater than or equal to 2 age-based systemic inflammatory response syndrome criteria, 2) confirmed or suspected invasive infection, and 3) cardiovascular dysfunction, acute respiratory distress syndrome, or greater than or equal to 2 organ system dysfunctions
Exclusion criteria
* Infants and children with history of prematurity (\< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, surgical conditions and any other chronic medical condition. * Those who are regularly taking vitamin or mineral supplementations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | through study completion an average of one year | Frequency of occurrence of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Zinc level | after 10 days of treatment | serum zinc level |
Countries
Egypt
Outcome results
None listed