Comparison of the effect of ampicillin and cefotaxime antibiotics with ampicillin and amicacin in the treatment of early neonatal sepsis
Design
This is a parallel randomized controlled clinical trial that will be performed on 94 infants with early sepsis. Randomization in this research is done using quadri blocks using syntax written in SPSS program. The duration of the study will be 3 months.
Settings and conduct
This study is a clinical trial study with a control group that will be performed on a total of 94 infants referred to Bahar Shahroud Hospital. Patients' parents must sign an informed consent form before entering the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Infants with early sepsis in the first 7 days of life; existence of respiratory distress, acute respiratory distress syndrome; urinary output less than 0.5 cc / kg / hr; metabolic acidosis ; cardiovascular instability; 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; congenital heart disease; severe asphyxia (Apgar 5 minutes less than 5).
Intervention groups
Patients included in the study will be divided into intervention and control groups. In the intervention group, treatment with ampicillin and cefotaxime antibiotics will be performed. In the control group, treatment with ampicillin and amikacin antibiotics will be performed.
Main outcome variables
Duration of making CRP marker negative; Need for intubation and mechanical ventilarion; Metabolic acidosis; duration of hospitalization and mortality rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N22
Registration date:2020-11-21, 1399/09/01
Registration timing:registered_while_recruiting
Last update:2020-11-21, 1399/09/01
Update count:0
Registration date
2020-11-21, 1399/09/01
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-20, 1399/08/30
Expected recruitment end date
2021-01-18, 1399/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of ampicillin and cefotaxime antibiotics with ampicillin and amikacin in the treatment of early neonatal sepsis
Public title
Comparison of the effect of ampicillin and cefotaxime with ampicillin and amikacin in the treatment of neonatal sepsis
Purpose
Treatment
Inclusion/Exclusion 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:
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);
Age
From 1 day old to 7 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into intervention and control groups according to random allocation table that illustrated by a statistician. Randomization will be done using permuted block randomization method (Block size of 4) using blocked random allocation syntax in SPSS software. Sample size will be 94 and number of blocks will be 24. Allocation concealment will be done using closed opaque envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Approval date
2020-10-25, 1399/08/04
Ethics committee reference number
IR.SHMU.REC.1399.111
Health conditions studied
1
Description of health condition studied
Early neonatal sepsis
ICD-10 code
A41
ICD-10 code description
Other sepsis
Primary outcomes
1
Description
Duration of making CRP marker negative
Timepoint
At the beginning and during the study
Method of measurement
laboratory tests
2
Description
Need for intubation and mechanical ventilarion
Timepoint
During the study
Method of measurement
Checking patient records
3
Description
Metabolic acidosis
Timepoint
During the study
Method of measurement
Laboratory test (ABG)
Secondary outcomes
1
Description
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.
2
Description
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.
Intervention groups
1
Description
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 cefotaxime 50 mg / kg will be given intravenously every 12 hours.
Category
Treatment - Drugs
2
Description
Control group: In the control group, as in the intervention group, while performing initial and routine procedures including hospitalization in the NICU, serum therapy and oxygen therapy and stabilization of vital signs, ampicillin 50 mg / kg with amikacin 7.5 mg / kg will be administered intravenously every 12 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar Hospital of Shahroud
Full name of responsible person
Dr. Mahboobeh Mohammadi
Street address
Bahar Hospital., End 22 Bahman street., Shahroud , Iran
City
Shahroud
Province
Semnan
Postal code
3616633255
Phone
+98 23 3224 5376
Fax
+98 23 3233 3902
Email
m_m361kord@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Vice chancellor for research; Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mahya Esmaili
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahar Hospital, End 22 Bahman street, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3616633525
Phone
+98 23 3224 5376
Email
mahya.me.esmaili@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mahboobeh Mohammadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neonatalogy
Street address
Bahar hospital., End 22 Bahman street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616622355
Phone
+98 23 3224 7653
Fax
+98 23 3233 3902
Email
m_m361kord@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available