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Once daily dose of Amikacin versus twice daily dose for treatment of early onset neonatal sepsis

Once daily dose of Amikacin versus twice daily dose for treatment of early onset neonatal sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201112248507N1
Enrollment
32
Registered
2012-01-10
Start date
2011-01-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Neonatal sepsis. P36.8

Interventions

Intervention 1: Control group: treated with Amikacin twice dose of 10 mg/ kg body weight daily that is within one hour intravenous infusion. Intervention 2: Case group: treated with amikacin one dose
Treatment - Drugs
Control group: treated with Amikacin twice dose of 10 mg/ kg body weight daily that is within one hour intravenous infusion.
Case group: treated with amikacin one dose of 15 mg /kg body weight that is within one hour intravenous infusion.

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Term Infants with the clinical signs of sepsis in premature newborn infants admitted Bou Ali Sina Hospital of Sari treated with Ampicillin plus Amikacin. Exclusion criteria : fetal age more than 42 Weeks and less than 37 weeks; Low birth weight; having congenital heart disease and asphyxia; not treated with Ampicillin and Amikacin at the age of 7 days; renal and hearing congenital disorders; prescription medications that have toxic effect on renal and auditory systems; neonatal meningitis; pathologic icter and TORCH Infections.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The treatment of SDL peak in therapeutic range. Timepoint: Sixty minutes after intramuscular administration or 30 minutes after intravenous administration in the range 15 -30. Method of measurement: Serum samples.;The treatment of through SDL in non-toxic range. Timepoint: Sixty minutes after intramuscular administration or 30 minutes after intravenous administration in the range 15 -30. Method of measurement: Serum samples.

Secondary

MeasureTime frame
Potential renal side effects. Timepoint: Before the next dose. Method of measurement: Serum samples.;Potential hearing side effects. Timepoint: Before the Next Dose. Method of measurement: Auditory brainstem response and audiometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohammadsadegh Rezai

Mazandaran University of Medical Sciences

rezai@mazums.ac.irdrmsrezaii@yahoo.com+98 15 1325 7230

Outcome results

None listed

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