Status:
COMPLETED
The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis
Lead Sponsor:
Universitas Sebelas Maret
Conditions:
Sepsis Newborn
Eligibility:
All Genders
28-36 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis. The main question aim to answer : • Does m...
Eligibility Criteria
Inclusion
- Newborns with gestational age of 28-36+6 weeks, birth weight according to gestational age, and diagnosis of sepsis based on HPS and PRS sepsis score criteria
Exclusion
- Major congenital anomalies of the gastrointestinal tract.
- Continuous vomiting.
- Newborns with hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage, feeding intolerance, necrotizing enterocolitis (NEC) and hormonal disorders.
- Septic shock.
Key Trial Info
Start Date :
April 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06191523
Start Date
April 27 2023
End Date
October 20 2023
Last Update
January 5 2024
Active Locations (1)
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1
Dwi Hidayah
Surakarta, Central Java, Indonesia, 57126