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

Phase 2

Recruiting

• Conditions: Early neonatal sepsis.; Other sepsis

• Registration Number: IRCT20100102002954N22
• Lead Sponsor: Shahroud University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 94

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

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);

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.