Evaluation of the effect of melatonin in the treatment of sepsis
Phase 3
Recruiting
- Conditions
- sepsis in neonates.Bacterial sepsis of newborn, unspecifiedP36.9
- Registration Number
- IRCT20210825052289N1
- Lead Sponsor
- Ardabil University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Parental consent
Infants under one month of age
Diagnosis of sepsis according to clinical and laboratory criteria
NPO patient(Non Pre Oral)
absence of any underlying disease
infants with gestational age above 37 weeks
Exclusion Criteria
Parental dissatisfaction
Death of the patient during melatonin administration
Existence of congenital anomalies
Existence of severe sepsis
Presence of congenital heart disease
PO intolerance and frequent vomiting
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method White blood cell. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample.;C-Reactive Protein. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample.;Interleukin-6. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample.
- Secondary Outcome Measures
Name Time Method eonates general status. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Based on Attending's evaluation in 3 categories: Well, Ill and Toxic.;Poorfeeding. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Based on Attending's evaluation.;Outcome. Timepoint: Upon discharge. Method of measurement: Death or Living based on Attending's evaluation.;Length of hospital stay. Timepoint: Upon discharge. Method of measurement: Based on date's submitted to patient profile.