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effect of Melatonin and probiotics in late onset neonatal sepsis

The effect of Melatonin and probiotics in late onset neonatal sepsis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250106064286N1
Enrollment
60
Registered
2025-07-16
Start date
2024-08-22
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late onset neonatal sepsis. Bacterial sepsis of newborn

Interventions

Intervention 1: Control group: The antibiotics include meropenem 30mg/kg q8hr and vancomycin 10mg/kg q8hr, which were prescribed for 7 days through the intravenous route and manufactured by the Dana c

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Days to 90 Days

Inclusion criteria

Inclusion criteria: all neonates age more than 3 days old suspicious for sepsis neonates having a birth weight which is more than 2 kilograms diagnosed with a late onset neonatal sepsis neonates more than 3 days old with fever and central core temperature more than 38 degrees or less than 36 degrees centigrade neonates with a positive blood or urine culture neonates aged more than 3 days old with tachycardia or tachypnoea neonates aged more than 3 days old with leukocytosis or leukopenia

Exclusion criteria

Exclusion criteria: birth weight less than 2 kilogram Premature neonates with gestational age of less than 37 weeks congenital anomalies ventilator dependent neonates asphyxiated neonates neonates who can not be feed orally

Design outcomes

Primary

MeasureTime frame
Sepsis scores which are probable and highly probable. Timepoint: sepsis scores were calculated before treatment and 72 hours after treatment. Method of measurement: blood tests include blood culture, complete blood count (CBC), C-reactive protein (CRP), urine culture, clinical status.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Nikafarin

Iran University of Medical Sciences

Saranikafarin@gmail.com+98 21 2222 2041

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026