The study of efficacy of Pentoxifylline in late sepsis in preterm neonate
Design
Randomized,paralled group,single blind clinical trial design include 40 patients,phase 3.
Settings and conduct
This study will be conducted on preterm neonate with diagnosis of late onset sepsis who hospitalized in NICU of Alzahra hospital.A randomized, clincal trial as a pilot study, will be done on 40 preterm with known sepsis.these neonates are randomly divided into two groups.one group will be receive Pentoxyfilin orally at a dose of 10 mg/kg every 8 hours for 6 day with routin antibiotic treatment.the other group will only receive routin antibiotic treatment. Demographic, clinical and lab date will be collected at baseline and at the end of 1 week of intervention initiation and will be compared bystatistical analysis with SPSS
Participants/Inclusion and exclusion criteria
Inclusion criteria:Preterm neonate with positive blood culture of late onset sepsis
clinical signs of sepsis:temprature instability-respiratory disorders-cardiovascular disorders-gastrointestinal disorders
Exclusion criteria:neonate with cranial hemorrhage-maternal infection
-renal disorders-neonate with tolerance to xanthine products that cause anaphylactic reaction
Intervention groups
Intervention group:Will be received Pentoxyfilin orally at a dose of 10 mg/kg every eight hours for 6 days with routin antibiotic treatment(Amikacin-Vancomycin)
Control group: will be received routin antibiotic for sepsis(Amikacin at a dose of 15-20 mg\kg-Vankomycin at a dose of 45-60 mg\kg\day divided every 6-8 hours) with supportive oxygen therapy.
Main outcome variables
Number of hospitalized days, Duration of making CRP marker negative,Need for intubation and mechanical ventilarion,Metabolic acidosis, Duration needed for oxygene therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039187N7
Registration date:2020-06-22, 1399/04/02
Registration timing:registered_while_recruiting
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Elnaz Shaseb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2250
Email address
shasebe@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of efficacy of Pentoxifylline in late Sepsis in preterm neonate(Trial clinical randomized)
Public title
evaluation effect of Pentoxifylline in sepsis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm neonate with positive blood culture of sepsis
clinical signs of sepsis:
temprature instability
respiratory disorders
cardiovascular disorders
gastrointestinal disorders
preterm neonates with late onset sepsis(having sepsis 72 hours after birth)
Exclusion criteria:
neonate with cranial hemorrhage
maternal infection
renal disorders
neonate with tolerance to xanthine products that cause anaphylactic reaction
Age
To 259 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Arrangement of the randomization process:
1) Determining the volume of each block (quadruple blocks)
2) Preparing the list of the blocks and assigning a number to each of them
AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6)
3) Choosing random numbers between 1 and 6
4) Defining the treatment assignment list
For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants (patients) are all blind during the study. At the patient's level, blindness will be done as the patients do not know in which group (control or intervention group) they are in. only The researcher has been informed and prescribes to patients according to the randomized list.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-12-25, 1398/10/04
Ethics committee reference number
IR.TBZMED.REC.1398.996
Health conditions studied
1
Description of health condition studied
neonatal late sepsis
ICD-10 code
A41
ICD-10 code description
Other sepsis
Primary outcomes
1
Description
Number of hospitalized days
Timepoint
During the study
Method of measurement
Count the days of hospitalization
2
Description
Duration of making CRP marker negative
Timepoint
At the beginning and during the study
Method of measurement
laboratory tests
3
Description
Need for intubation and mechanical ventilarion
Timepoint
During the study
Method of measurement
Checking patient records
4
Description
Metabolic acidosis
Timepoint
During the study
Method of measurement
Laboratory test(ABG)
5
Description
Duration needed for oxygene therapy
Timepoint
During the study
Method of measurement
Counting days under oxygen therapy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: received Pentoxyfilin orally at a dose of 10 mg/kg every eight hours for 6 day with routin antibiotic treatment(Amikacin at a dose of 15-20 mg\kg-Vankomycin at a dose of 45-60 mg\kg\day divided every 6-8 hours)
Category
Treatment - Drugs
2
Description
Control group: received routin antibiotic for sepsis(Amikacin at a dose of 15-20 mg\kg-Vankomycin at a dose of 45-60 mg\kg\day divided every 6-8 hours with supportive oxygen therapy)