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

NCT03295162 | Completed Phase 1 DMC

• 1 other identifier: Pediatrics Dept-ASU
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

• Melatonin as an antioxidant and free radicals scavenger in Neonatal sepsis

  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

  3 days

Secondary Outcomes (1)

• melatonin as an adjuvant in management of neonatal sepsis

  3 days

Study Arms (3)

Sepsis A Group

EXPERIMENTAL

neonates diagnosed with Sepsis and will receive melatonin. 10 mg product as a total dose of 20 mg .together with conventional treatment of Neonatal sepsis

Drug: Melatonin 10 mg; Combination Product: Conventional treatment of neonatal sepsis

Sepsis B Group

SHAM COMPARATOR

neonates diagnosed with Sepsis and willnot receive melatonin., they will recieve only the conventional treatment of Neonatal Sepsis

Combination Product: Conventional treatment of neonatal sepsis

Control

NO INTERVENTION

healthy neonates, in whom sepsis will be ruled-out on the basis of absence of any clinical or laboratory evidence suggestive of infection.

Interventions

Melatonin 10 mg DRUG

Melatonin will be given at a total dose of 20 mg dissolved in 4 ml of distilled water via enteral route in two doses of 10 mg each(2 ml ), with a 1-hour interval. to one group together with conventional treatment

Sepsis A Group

Conventional treatment of neonatal sepsis COMBINATION_PRODUCT

Conventional treatment of neonatal sepsis including antibiotics,IV fluids, Total Parenteral Nutrition,etc...

Sepsis A Group; Sepsis B Group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants ( less than 37 weeks gestational age). Evidence of neonatal sepsis

You may not qualify if:

• Infants with hypoxic ischemic encephalopath Infants on nothing per os. Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.

Sponsors & Collaborators

• Mohamed Hussein Metwally: lead

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 27, 2017
• Study Start: November 26, 2015
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 27, 2017

Record last verified: 2017-09