The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis

Sepsis Newborn Clinical Trial

Official title:

The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis (Review of Malondialdehyde, Interleukin-6, Interleukin-8, Absolute Neutrophil Counts, and Sepsis Score)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06191523
• Other study ID #: 1.657/XII/HREC/2022
• Status: Completed
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: December 2023
• Source: Universitas Sebelas Maret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 20, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Sepsis Newborn
• Toxemia

Intervention

Other:
• Control Group
The control group will receive standard therapy and placebo.

Drug:
• Treatment Group
The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg

Locations

Country	Name	City	State
Indonesia	Dwi Hidayah	Surakarta	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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