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Comparison of the effect of ampicillin and cefotaxime with ampicillin and amikacin in the treatment of neonatal sepsis

Comparative study of the effect of ampicillin and cefotaxime antibiotics with ampicillin and amikacin in the treatment of early neonatal sepsis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100102002954N22
Enrollment
94
Registered
2020-11-21
Start date
2020-11-20
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Early neonatal sepsis. Other sepsis

Interventions

Intervention 1: Intervention group: After initial and routine procedures including NICU admission, serum therapy and oxygen therapy, and stabilization of vital signs, ampicillin 50 mg / kg with cefota

Sponsors

Shahroud University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 7 Days

Inclusion criteria

Inclusion criteria: Infants with early sepsis in the first 7 days of life; Existence of respiratory distress, hypoxia or symptoms of acute respiratory distress syndrome; Poor perfusion or urinary output less than 0.5 cc / kg / hr; Metabolic acidosis with pH <7.2; Cardiovascular instability with a heart rate of less than 160 beats per minute; Decreased infant reflexes; Severe cyanosis; Frequent or prolonged seizures; Increase in body temperature to more than 38.5 or less than 36 ° C axillary; Apnea; Severe abdominal distension; And informed consent of parents to participate in the research.

Exclusion criteria

Exclusion criteria: Infants with major congenital anomalies; Severe prematurity and less than 28 weeks; Very low birth weight (less than 1500 g); Congenital heart disease; Severe asphyxia (Apgar 5 minutes less than 5);

Design outcomes

Primary

MeasureTime frame
Duration of making CRP marker negative. Timepoint: At the beginning and during the study. Method of measurement: laboratory tests.;Need for intubation and mechanical ventilarion. Timepoint: During the study. Method of measurement: Checking patient records.;Metabolic acidosis. Timepoint: During the study. Method of measurement: Laboratory test (ABG).

Secondary

MeasureTime frame
Duration of hospitalization. Timepoint: At the end of the study. Method of measurement: The time between the time / date of hospitalization and the time / date of discharge from the hospital, expressed in hours.;Mortality rate. Timepoint: At the end of the study. Method of measurement: Mortality rate refers to the number of deaths among these infants, expressed as a percentage.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mahya Esmaili

Shahroud University of Medical Sciences

mahya.me.esmaili@gmail.com+98 23 3224 5376

Outcome results

None listed

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