NCT06191523

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 melatonin affect MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis? The participants in the treatment group will receive a single dose of oral melatonin 20 mg, meanwhile those the control group will receive placebo. The researchers will compare MDA serum, IL-6, IL-8 levels, ANC, and sepsis score before and after receiving melatonin, whether there are decreases of MDA serum, IL-6, IL-8 levels, ANC and increase of sepsis score

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

December 19, 2023

Last Update Submit

December 20, 2023

Conditions

Sepsis Newborn

Keywords

melatoninsepsispreterm neonates

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System

    From enrollment to the end of treatment at 6 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

The control group will receive standard therapy and placebo.

Other: Control GroupDrug: Treatment Group

Treatment Group

EXPERIMENTAL

The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg

Other: Control GroupDrug: Treatment Group

Interventions

Control GroupOTHER

The control group will receive standard therapy and placebo.

Control GroupTreatment Group
Treatment GroupDRUG

The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg

Control GroupTreatment Group

Eligibility Criteria

Age28 Weeks - 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dwi Hidayah

Surakarta, Central Java, 57126, Indonesia

Location

Related Publications (4)

  • Henderson R, Kim S, Lee E. Use of melatonin as adjunctive therapy in neonatal sepsis: A systematic review and meta-analysis. Complement Ther Med. 2018 Aug;39:131-136. doi: 10.1016/j.ctim.2018.06.002. Epub 2018 Jun 11.

    PMID: 30012383RESULT

  • Gitto E, Karbownik M, Reiter RJ, Tan DX, Cuzzocrea S, Chiurazzi P, Cordaro S, Corona G, Trimarchi G, Barberi I. Effects of melatonin treatment in septic newborns. Pediatr Res. 2001 Dec;50(6):756-60. doi: 10.1203/00006450-200112000-00021.

    PMID: 11726736RESULT

  • El-Gendy FM, El-Hawy MA, Hassan MG. Beneficial effect of melatonin in the treatment of neonatal sepsis. J Matern Fetal Neonatal Med. 2018 Sep;31(17):2299-2303. doi: 10.1080/14767058.2017.1342794. Epub 2017 Jul 6.

    PMID: 28612668RESULT

  • El Frargy M, El-Sharkawy HM, Attia GF. Use of melatonin as an adjuvant therapy in neonatal sepsis. J Neonatal Perinatal Med. 2015;8(3):227-32. doi: 10.3233/NPM-15814072.

    PMID: 26485549RESULT

MeSH Terms

Conditions

Neonatal SepsisSepsis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

InfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Program

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

April 27, 2023

Primary Completion

October 5, 2023

Study Completion

October 20, 2023

Last Updated

January 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)