Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis
NCT ID: NCT03295162
Last Updated: 2017-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
55 participants
INTERVENTIONAL
2015-11-26
2017-09-01
Brief Summary
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Detailed Description
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Inclusion criteria:
The study will include:Preterm infants (less than 37 weeks gestational age). Evidence of neonatal sepsis.
Exclusion Criteria: Neonate with evidence of any of the following will be excluded:
Infants with hypoxic ischemic encephalopathy. Infants on nothing per os. Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.
Group Classification:
Studied neonates will be completely evaluated and subsequently discriminated, into 2 main groups:Sepsis group: including neonates with proved sepsis. These will be subsequently randomized by permuted block randomization according to sequence of enrollment into:Subgroup A: neonates with odd numbers will receive melatonin.
Subgroup B: neonates with even numbers will not receive the medicine. Non Sepsis group: healthy neonates, in whom sepsis will be ruled-out on the basis of absence of any clinical or laboratory evidence suggestive of infection.
Diagnosis of neonatal sepsis will be established based on the presence of: risk factors of sepsis (e.g., prematurity, chorioamnionitis), any clinical evidence suggestive of sepsis, quantitative C-reactive protein (CRP) levels ≥6 mg/dL, Rodwell's hematological scores ≥3, with or without positive blood culture results
1. Comprehensive history taking including:
A.Antenatal history: Maternal age, maternal diseases; Maternal diabetic control, maternal fever, infection, prolonged rupture of membranes \>=18 hours, malodorous vaginal discharge.
B.Natal history: Gestational age, sex, and mode of delivery. C.Postnatal history: APGAR score, Respiratory distress and/or cyanosis.
2. Gestational age will be estimated using the date of the last menstrual period, early antenatal ultrasound if present when available and confirmed by the new Ballard scoring system
3. Full clinical examination including: chest, cardiac, abdominal and neurological examination.
4. Clinical signs of infection: lethargy, irritability, prolonged capillary refill, tachycardia, respiratory distress, apnea, convulsions, abdominal distension, feeding intolerance, hyperglycemia, temperature instability and bleeding.
5. Assessment of the hemodynamic state of the neonates: mean arterial blood pressure (MABP), urinary output, temperature, capillary refill time.
6. Laboratory investigations Complete blood picture (CBC) with differential leucocytic count. C- reactive protein (CRP) quantitative assay. Blood cultures. MDA assay: blood samples will be collected in plain tubes from peripheral veins or central venous access. Samples will be allowed to clot before centrifugation for 15 minutes and serum will be stored at (-20 degree C) until MDA analysis using MDA competitive ELISA-kit.
Blood samples will be collected from all included neonates at enrollment and in day one for healthy group.
As for subgroup A, other samples will be withdrawn at 4 and 72 hours after melatonin administration to assess serum level of malondialdehyde while for subgroup B another sample will be withdrawn after 72 hours
7. Melatonin Medication:
Melatonin 10 mg rapid release capsules (puritans pride) will be used. 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.(Gitto et al., 2000)
8. Treatment protocol: All neonates will be managed according to the protocol of NICU beside routine neonatal care.
Babies admitted to NICU will be bathed, placed in incubator, attached to monitor.
Cannula will be inserted, IV fluids is started and IV antibiotics. If there is respiratory distress: O2 or ventilation is started, usually feeds are delayed to day 2 or day 3 (or even later) according the severity of condition (clinical decision according to the attending neonatologist).
If no distress and the baby is well: trophic feeds will be started (10ml/kg/day milk), feeds are increased in 10-20ml/kg/day according to baby tolerance, and the condition of the baby (clinical decision according to the attending neonatologist), IV fluids are reduced gradually.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
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
Conventional treatment of neonatal sepsis
Conventional treatment of neonatal sepsis including antibiotics,IV fluids, Total Parenteral Nutrition,etc...
Sepsis B Group
neonates diagnosed with Sepsis and willnot receive melatonin., they will recieve only the conventional treatment of Neonatal Sepsis
Conventional treatment of neonatal sepsis
Conventional treatment of neonatal sepsis including antibiotics,IV fluids, Total Parenteral Nutrition,etc...
Control
healthy neonates, in whom sepsis will be ruled-out on the basis of absence of any clinical or laboratory evidence suggestive of infection.
No interventions assigned to this group
Interventions
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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
Conventional treatment of neonatal sepsis
Conventional treatment of neonatal sepsis including antibiotics,IV fluids, Total Parenteral Nutrition,etc...
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
28 Days
ALL
Yes
Sponsors
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Mohamed Hussein Metwally
OTHER
Responsible Party
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Mohamed Hussein Metwally
Assistant Lecturer
Other Identifiers
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Pediatrics Dept-ASU
Identifier Type: -
Identifier Source: org_study_id