NCT05971485 is a Phase 2 clinical trial of Melatonin 10 mg in Preterm Neonate Analgesia, sponsored by Ain Shams University.

Who is sponsoring NCT05971485?

NCT05971485 is sponsored by Ain Shams University.

What drugs are being tested in NCT05971485?

Interventions in NCT05971485: Melatonin 10 mg, Placebo.

What condition does NCT05971485 study?

NCT05971485 studies Preterm Neonate Analgesia.

Is NCT05971485 still recruiting?

NCT05971485 is currently completed. Last updated 16 January 2025.

Last reviewed 2025-01-16 · How we verify

NCT05971485

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

Melatonin As an Analgesic in Preterm Neonate

Completed Phase 2 Last updated 16 January 2025

What this trial tests

Phase 2 trial testing Melatonin 10 mg in Preterm Neonate Analgesia in 40 participants. Completed in 30 October 2024.

Timeline

20 August 2022

Primary endpoint
30 September 2024

30 October 2024

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	20 August 2022
Primary completion	30 September 2024
Estimated completion	30 October 2024
Sites	1 location across Egypt

Drugs / interventions tested

Melatonin 10 mg — full drug profile →
Placebo

Conditions studied

Preterm Neonate Analgesia — all drugs for Preterm Neonate Analgesia →

Sponsor

Ain Shams University

Who can join

Under 28 Days, any sex, with Preterm Neonate Analgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of enteral melatonin given 30 minutes before cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Additionally, the study aimed to explore the relationship between procedural pain and oxidative stress, along with the effectiveness of pain management of melatonin by measuring Malondialdehyde (MDA), a well-accepted marker of oxidative stress, 60 minutes after the procedure.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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
NCT03782740 — Effect of Melatonin on Reduction of Pelvic Pain · Phase 2 · completed
NCT03295162 — Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis · Phase 1, PHASE2 · completed
NCT03121521 — The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment · Phase 4 · completed

Other Ain Shams University trials

Trials by the same sponsor.

NCT07435493 — Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstru · NA · not yet recruiting
NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
NCT07531030 — Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blo · NA · not yet recruiting
NCT06839027 — Arterial to Central co2gap in Relation to Outcome After Cardiopulmonary Bypass · not yet recruiting
NCT07516535 — DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones · NA · not yet 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 NCT05971485 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
Last refreshed: 16 January 2025

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/NCT05971485.

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