1. Home
  2. Approved trials
  3. » فارسی

Comparison of Restricted fluid volume with Standard Fluid volume In management of Transient Tachypnea Of Newborn

Protocol summary

Study aim
Comparison of Restricted fluid volume with Standard Fluid volume In management of Transient Tachypnea Of Newborn
Design
clinical trial,with control group,based on social and actual ,with a paralel group,single blind ,rondomised
Settings and conduct
This study was done in Besat and Fatemieh hospitals during 15 months. In two groups(standard and study) check lists completed and data were analysed.single blind considered for standard group.
Participants/Inclusion and exclusion criteria
Newborns with gestational age 37 to 41 with Transient Tachypnea of Newborn that are hospitalized in 3 first days of birth .Exclusion criteria: Critical events of perinatal problems include congenital malformations ,systemic infection ( confirmed by positive blood culture) ,meconium aspiration ,respiratory distress syndrome(confirmed by graphy),intrauterine growth retardation, pneumonia, congenital heart disease, multi organ failure, DIC, hypocalcemia, hypoglycemia, polycytemia, , Na> 150,Bun>20,K>5,Urine volume <1cc/kg/hr
Intervention groups
Newborns with gestational age 37 to 41 with Transient Tachypnea of Newborn that are hospitalized in 3 first days of birth .
Main outcome variables
Transient Tachypnea of Newborn ; restricted fluid therapy; O2 therapy with hood; O2 therapy with N-CPAP; O2 therapy with ventilator

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120925010933N10
Registration date: 2018-02-01, 1396/11/12
Registration timing: retrospective

Last update: 2018-02-01, 1396/11/12
Update count: 0
Registration date
2018-02-01, 1396/11/12
Registrant information
Name
Fatemeh Eghbalian
Name of organization / entity
Hamadan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 3978
Email address
eghbalian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2016-02-20, 1394/12/01
Actual recruitment end date
2017-10-23, 1396/08/01
Trial completion date
empty
Scientific title
Comparison of Restricted fluid volume with Standard Fluid volume In management of Transient Tachypnea Of Newborn
Public title
Effect of fiuid therapy on Transient Tachypnea of Newborn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria : Newborns with gestational age 37 to 41 with Transient Tachypnea of Newborn that are hospitalized in 3 first days of birth
Exclusion criteria:
معیار های خروج از مطالعه : وجود حوادث وخیم پری ناتال نوزادان شامل ناهنجاری های مادر زادی، عفونت سیستمیک اثبات شده (کشت خون مثبت) ،اسپیراسیون مکونیوم،سندرم دیسترس تنفسی(بر اساس گرافی)، تاخیر رشد داخل رحمی، پنومونی، بیماری مادرزادی نارسایی چند ارگانی،انعقاد داخل عروقی منتشر، هیپوکالسمی،هیپو گلیسمی،پلی سایتمی، حجمNa>150 ،Bun>20 K>5قلبی ، ادرارکمتراز1سی سی پر کیلو گرم در ساعت
Age
From 148 days old to 287 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized
Blinding (investigator's opinion)
Single blinded
Blinding description
Control group(standard) of fluid therapy:In standard group that recieved standard fluid therapy ,didnot have information about this research
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity Of Medical Sciencse
Street address
Shahid Fahmide Ave,Hamadan Univercity Of Medical Sciencse, Hamedan, Iran
City
Hamadan
Province
Hamadan
Postal code
6516837634
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.UMSHA.REC.1395.153

Health conditions studied

1

Description of health condition studied
Transient tachypnoea of newborn
ICD-10 code
P22.1
ICD-10 code description
Transient tachypnea of newborn

Primary outcomes

1

Description
Transient Tachypnea Of Newborn
Timepoint
daily
Method of measurement
observation and record of respirtory rate per minute

Secondary outcomes

1

Description
O2 requirement
Timepoint
daily
Method of measurement
per liter. per minute

2

Description
hospitalization
Timepoint
date of discharge
Method of measurement
day

Intervention groups

1

Description
Intervention group: First interventional group(control group) : Newborn with gestational age 37 to 41weeks and receipt srandard fluid therapy.second interventional group(study group) : Newborn with gestational age 37 to 41weeks and receipt restricted fluid therapy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital- - Neonatal Ward
Full name of responsible person
Dr. Fatemeh Eghbalian
Street address
Besat hospital, Motahari Ave, Hamedan, Iran.
City
hamadan
Province
Hamadan
Postal code
651484411
Phone
+98 81 3264 0020
Email
eghbalian@umsha.ac.ir

2

Recruitment center
Name of recruitment center
fatemieh hospital
Full name of responsible person
Dr.fatemeh eghbalian
Street address
pasdaran street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7082
Email
eghbalian@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Eghbalian
Street address
Mahdie Ave, Hamadan University of Medical Sciences,Hamadan,Iran
City
hamadan
Province
Hamadan
Postal code
32640020
Phone
+98 81 3264 0020
Email
Eghbalian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr.eghbalian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal Ward, Besat hospital, Motahari Ave, Hamedan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0020
Email
eghbalian@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.fatemeh eghbalian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal Ward, Besat hospital, Motahari Ave, Hamedan, Iran.
City
hamadan
Province
Hamadan
Postal code
6514845411
Phone
+81 32640020
Email
eghbalian@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.fatemeh eghbalian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bessat Hospital, Motahari Ave, Hamedanl Iran
City
hamadan
Province
Hamadan
Postal code
6514845411
Phone
+81 32640020
Email
eghbalian@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...