Comparison of the efficacy and safety of Aminophylline and caffeine in treatment of prematurity apnea
Design
Randomised clinical trial with 2 group that treatment by caffeine in one group and other group treatment by aminophilin,parallel , double blind ,randomised .
Settings and conduct
Randomised clinical trial with 2 group treatment with caffeine 30mg /kg stat and then 15mg/kg /day and other group that treatment with aminophylin 5mg /kg stat and then 2mg /kg /q8h then 3 days after treatment evaluate for episode of apnea and complication for example hypoglycemi, tachycardia,irritability ,seizure,vomiting
Participants/Inclusion and exclusion criteria
neonate with apnea of prematurity and GA less than 34 week that was not due to sepsis ,hypoglycemia: BS<50,heart disease and was not intubated .
Intervention groups
Treatment with aminophilin and treatment with caffeine
Main outcome variables
Recurrence of apnea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181110041605N1
Registration date:2019-01-16, 1397/10/26
Registration timing:retrospective
Last update:2019-01-16, 1397/10/26
Update count:0
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Elahe Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 3910
Email address
e.jafari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
2018-03-06, 1396/12/15
Actual recruitment end date
2018-10-07, 1397/07/15
Trial completion date
2018-11-07, 1397/08/16
Scientific title
Comparison of the effect of caffeine with Aminophylline in treatment of prematurity apnea in preterm neonate (<34 weeks) that admitted in NICU
Public title
Comparison of effectiveness of caffeine with Aminophylline in treatment of prematurity apnea in preterm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonate with apnea of prematurity that was GA <34 WEEK
Exclusion criteria:
Neonate with apnea of prematurity that not due to sepsis ,heart disease , hypoglycemi ,was not intuba
Age
From 1 day old to 10 days old
Gender
Both
Phase
0
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher , doctors, nurses, data safety and monitoring committee
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi university of medical Sciences
Street address
Ebnesina Ave
City
Yazd
Province
Yazd
Postal code
8915887857
Approval date
2018-09-10, 1397/06/19
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.078
Health conditions studied
1
Description of health condition studied
Apnea of Prematurity
ICD-10 code
J98.9
ICD-10 code description
Respiratory disorder, unspecified
Primary outcomes
1
Description
Recurrence of apnea
Timepoint
72 hours after treatment
Method of measurement
Analysis of recurrence of apnea in 72 hours after treatment
Secondary outcomes
1
Description
Complication of drugs and recurrence of apnea
Timepoint
72 hours after treatment
Method of measurement
Analysis of complication of drugs in 72 hours after treatment
Intervention groups
1
Description
Intervention group: treatment with caffein
Category
Treatment - Drugs
2
Description
Control group: treatment with aminophillin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Yazd hospital
Full name of responsible person
Elahe Jafari
Street address
Ebnesina Ave
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Fax
+98 35 3822 4000
Email
e.jafari@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masoud Mirzaei
Street address
Ebnesina Ave.
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
e.jafari@ssu.ac.irr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical 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
Yazd University of Medical Sciences
Full name of responsible person
Elahe jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ebnesina Ave.
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
e.jafari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Elahe Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ebnesina Ave.
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
e.jafari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Elahe Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ebnesina Ave.
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
e.jafari@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD