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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295162
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Hussein Metwally, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Neonatal Sepsis Drug: Melatonin 10 mg Combination Product: Conventional treatment of neonatal sepsis Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis
Actual Study Start Date : November 26, 2015
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants Sepsis
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Sepsis A Group
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
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

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

Sham Comparator: Sepsis B Group
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
Conventional treatment of neonatal sepsis including antibiotics,IV fluids, Total Parenteral Nutrition,etc...

No Intervention: Control
healthy neonates, in whom sepsis will be ruled-out on the basis of absence of any clinical or laboratory evidence suggestive of infection.



Primary Outcome Measures :
  1. Melatonin as an antioxidant and free radicals scavenger in Neonatal sepsis [ Time Frame: 3 days ]
    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


Secondary Outcome Measures :
  1. melatonin as an adjuvant in management of neonatal sepsis [ Time Frame: 3 days ]
    efficacy of melatonin as an adjuvant in the treatment of septic preterms compared to those on conventional treatment and by comparing other clinical and laboratory parameters of sepsis in both groups



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


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Responsible Party: Mohamed Hussein Metwally, Assistant Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03295162    
Other Study ID Numbers: Pediatrics Dept-ASU
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Melatonin
Antioxidants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants