NCT03295162|CompletedPhase 1/2DMC
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Sponsor study identifier
interventional
55
0 countries
N/A
Study Start
November 26, 2015
Actual (reported)Primary Completion
March 1, 2017
Actual (reported)Study Completion
September 1, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 26, 2015
Actual (reported)March 1, 2017
Actual (reported)September 1, 2017
Actual (reported)September 25, 2017
Actual (reported)September 27, 2017
Actual (reported)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
melatonin as an adjuvant in management of neonatal sepsis
3 days
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
neonates diagnosed with Sepsis and willnot receive melatonin., they will recieve only the conventional treatment of Neonatal Sepsis
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
Conventional treatment of neonatal sepsis including antibiotics,IV fluids, Total Parenteral Nutrition,etc...
55 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2017
First Posted
September 27, 2017
Study Start
November 26, 2015
Actual (reported)Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis
healthy neonates, in whom sepsis will be ruled-out on the basis of absence of any clinical or laboratory evidence suggestive of infection.
Contact the study team to confirm eligibility.
Primary Completion
March 1, 2017
Actual (reported)Study Completion
September 1, 2017
Actual (reported)Last Updated
September 27, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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