Comparison between efficacy of aerosolized and intravenous furosemide on oxygen requirement in >10 days preterm neonate with oxygen dependency
Design
In this study 36 preterm neonates older than 10 days who have inclusion criterieon and admitted in Hafez and Namazi hospital will be entered . After administration of aerosolized and intravenous forms of furosemide, neonate will be checked for lab data.
Settings and conduct
The neonate who admitted at Namazi and Hafez NICU wards will be selected for this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: neonate with gestational age<32 week; birth weight <1500 gr; age >10 days; who are dependent to oxygen.
Exclusion criteria: neonate with major congenital anomalies; cyanotic heart disease; renal disease
Intervention groups
A group of 36 neonates who will receive aerosolized for fist time and intravenous forms of furosemide for next time.
Main outcome variables
Measuring Bun, Na,K
Measuring ABG
Measuring ca/cr ratio in urine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140311016936N2
Registration date:2019-09-07, 1398/06/16
Registration timing:registered_while_recruiting
Last update:2019-09-07, 1398/06/16
Update count:0
Registration date
2019-09-07, 1398/06/16
Registrant information
Name
Fariba Hemmati
Name of organization / entity
Shiraz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1612 5481
Email address
hemmatif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
2018-11-21, 1397/08/30
Actual recruitment end date
2019-10-23, 1398/08/01
Trial completion date
2019-10-23, 1398/08/01
Scientific title
Comparison between efficacy of aerosolized and intravenous furosemide on oxygen requirement in 10 days preterm neonate with oxygen dependency
Public title
Effect of aerosolized furosemide on the oxygen requirement of preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm neonates with gestational age < 32 weeks
Preterm neonates with birth weight <1500gr
Preterm neonates with age> 10 days
Preterm neonates who require oxygen
Exclusion criteria:
Neonate with major congenital anomalies
Neonate with cyanotic heart disease
Neonate with renal failure disease
Patient who needs corticosteroids in hospital course
Age
From 10 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
City
shiraz
Province
Fars
Postal code
34786-71946
Approval date
2018-11-18, 1397/08/27
Ethics committee reference number
IR.SUMS.MED.REC.1397.348
Health conditions studied
1
Description of health condition studied
Chronic lung disease of preterm neonates (CLD)
ICD-10 code
J70.2
ICD-10 code description
Acute drug-induced interstitial lung disorders
Primary outcomes
1
Description
Ca/Cr ratio of urine
Timepoint
Daily
Method of measurement
Laboratory measurement
2
Description
BUN ,Na, K serum
Timepoint
Before drug administration, 49 hours and 97 hours after first doses of drug
Method of measurement
Laboratory measurement
3
Description
ABG
Timepoint
Before drug administration, one hour after second and third dose
Method of measurement
Laboratory measurement
Secondary outcomes
empty
Intervention groups
1
Description
The premature neonates who had inclusion criteria were received aerosolized and intravenous furosemide, respectively.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazee hospital
Full name of responsible person
Dr.Ashkan NikAeen, Fariba Hemmati
Street address
Namazee square, Namazee hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3612 2218
Fax
+98 71 3612 2218
Email
hemmatif@sums.ac.ir
2
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Dr.Ashkan NikAeen, Fariba Hemmati
Street address
Chamran Blvd, Hafez Hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3612 8257
Fax
+98 71 3612 8257
Email
hemmatif@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Yoones Ghasemi
Street address
Zand street, Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ashkan Nik Aeen
Position
Neonatalogy flowship
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Namazee square, Namazee hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3612 2218
Email
ashkan.nikaeen@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariba hemmati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Namazee square, Namazee hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3612 2218
Email
hemmatif@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ashkan Nikaeen
Position
Neonatology flowship
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Namazee square, Namazee hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3612 2218
Email
ashkan.nikaeen@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information and research data informed consent form: Complete the informed consent form by the patient
When the data will become available and for how long