NCT03295162 is a Phase 1, PHASE2 clinical trial of Melatonin 10 mg in Neonatal Sepsis, sponsored by Mohamed Hussein Metwally.

Who is sponsoring NCT03295162?

NCT03295162 is sponsored by Mohamed Hussein Metwally.

What drugs are being tested in NCT03295162?

Interventions in NCT03295162: Melatonin 10 mg, Conventional treatment of neonatal sepsis.

What condition does NCT03295162 study?

NCT03295162 studies Neonatal Sepsis.

Is NCT03295162 still recruiting?

NCT03295162 is currently completed. Last updated 27 September 2017.

Last reviewed 2017-09-27 · How we verify

NCT03295162

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis

Completed Phase 1, PHASE2 Last updated 27 September 2017

What this trial tests

Phase 1, PHASE2 trial testing Melatonin 10 mg in Neonatal Sepsis in 55 participants. Completed in 1 September 2017.

Timeline

26 November 2015

Primary endpoint
1 March 2017

1 September 2017

Quick facts

Lead sponsor	Mohamed Hussein Metwally
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	55
Start date	26 November 2015
Primary completion	1 March 2017
Estimated completion	1 September 2017

Drugs / interventions tested

Melatonin 10 mg — full drug profile →
Conventional treatment of neonatal sepsis

Conditions studied

Neonatal Sepsis — all drugs for Neonatal Sepsis →

Sponsor

Mohamed Hussein Metwally

Who can join

Adults 1 Day to 28 Days, any sex, with Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Assess the efficacy of melatonin as an adjuvant in the treatment of free radical disease in septic preterms receiving melatonin compared to those on conventional treatment through measuring the level of Malondialdehyde as a marker of oxidative stress and by comparing other clinical and laboratory parameters of sepsis in both groups.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Melatonin as a master regulator of cell death and inflammation: molecular mechanisms and clinical implications for newborn care.
Tarocco A, Caroccia N, Morciano G, Wieckowski MR, et al · · 2019 · cited 187× · PMID 30962427 · DOI 10.1038/s41419-019-1556-7
Oxidative Stress and Inflammation in COVID-19-Associated Sepsis: The Potential Role of Anti-Oxidant Therapy in Avoiding Disease Progression.
Beltrán-García J, Osca-Verdegal R, Pallardó FV, Ferreres J, et al · · 2020 · cited 103× · PMID 33003552 · DOI 10.3390/antiox9100936
Endothelial Activation and Microcirculatory Disorders in Sepsis.
Raia L, Zafrani L. · · 2022 · cited 34× · PMID 35721048 · DOI 10.3389/fmed.2022.907992

Verify or expand the search:

Other trials of Melatonin 10 mg

Trials testing the same drug.

NCT07380568 — Melatonin on Post Operative Pain After CS · NA · recruiting
NCT05971485 — Melatonin As an Analgesic in Preterm Neonate · Phase 2 · completed
NCT03782740 — Effect of Melatonin on Reduction of Pelvic Pain · Phase 2 · completed
NCT03121521 — The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment · Phase 4 · completed

Other recruiting trials for Neonatal Sepsis

Currently open trials in the same condition.

NCT07421323 — Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection · NA · recruiting
NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03295162 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mohamed Hussein Metwally
Last refreshed: 27 September 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03295162.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing