Object: the effects of fluid restriction of fluid in treatment of transient tachypnea of newborn.Design: double blind randomized clinical trial with a control group.Intervention&metod:for 70 preterm, term and post term infants have TTN divide in two groups randomly, Control group with standard fluid regime administration (65ml/kg/d) and case group with (50ml/kg/d) fluid reception. In the following days in each group in the absence of contraindications Daily( 20ml / kg/d) is added to the liquid volume.inclusion criteria: The late preterm and term and post term neonates with tachypnea (Respiratory Rate greater than 60 per minute) with or without respiratory distress.Exclusion criteria: Pretem neonates; neonates with history of asphyxia; RDS; Air-block syndrom; birth trauma; congenital anomaly and; blood culture positive; receive surfactants; develop dehydration complication.Main outcom measure:reduce of respiratory rate; reduce of hospitalization; improvment of Retraction Score; improvment of Artrial Gases; reduce of O2 requirement
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122225650N1
Registration date:2016-03-07, 1394/12/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-07, 1394/12/17
Registrant information
Name
Mitra Gorji Rad
Name of organization / entity
Babol Medical Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 11 4425 9558
Email address
m.gorjirad@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Babol University of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of limitation of fluid in treatment of transient tachypnea of newborn
Public title
The effect of restriction of fluid in treatment of transient tachypnea of newborn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The late preterm (gestational age of 34 – 37 weeks) and term (gestational ageof 37 -42 weeks) and post term (gestational age greater than 42 weeks) neonates with tachypnea (Respiratory Rate greater than 60 per minute) with or without respiratory distress within 6 hours of birth. Exclusion criteria: Pretem neonates (gestational age less than 34 weeks); neonates with history of asphyxia;RDS;air-block syndrom; birth trauma; congenital anomaly and neonates with blood culture positive and also infants who receive surfactants while treatment or develop dehydration complication (weight loss more than one percent daily, reduce urine outflow to lower than (1cc /kg /hour) or increase urine specific gravity more than( 1/017) have excluded from study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The paitient selective alternatively
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee OF Babol University of Medical
Street address
Ganjafrooz street
City
Babol
Postal code
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
MUBABOL.REC.1394.8
Health conditions studied
1
Description of health condition studied
Transient tachypnea of newborn
ICD-10 code
P22.1
ICD-10 code description
Transient tachypnea of newborn
Primary outcomes
1
Description
Tachypnea
Timepoint
daily
Method of measurement
observation and record of respirtory rate per minute
Secondary outcomes
1
Description
reduce of hospitalization
Timepoint
date of discharge
Method of measurement
day
2
Description
Retraction Score
Timepoint
daily
Method of measurement
Oservation and record on bases of SILVERMAN - ANDERSON Retraction Score
3
Description
respiratory rate
Timepoint
daily
Method of measurement
observation and record of respirtory rate per minute
4
Description
Arterial Blood Gases
Timepoint
daily
Method of measurement
Blood sample
5
Description
O2 requirement
Timepoint
daily
Method of measurement
per liter. per minute
6
Description
level of respiratory support
Timepoint
daily
Method of measurement
severity
Intervention groups
1
Description
Intervention group:reception of fluid 50cc/kg/d
Category
Other
2
Description
Control group:reception of fluid 65 cc/kg/d
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Aiatollah Rohani Hospital
Full name of responsible person
Mitra Gorji Rad
Street address
Ganj afrooz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Yahyapoor Yoosef
Street address
Babol University of Medical Sciences, Ganjafrooze street
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mitra Gorji Rad
Position
resident of pediatric
Other areas of specialty/work
Street address
Ganjafrooz street, Ayatollah Rohani hospital
City
Babol
Postal code
Phone
+98 11 3219 2832
Fax
Email
m.gorjirad@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Haghshenas Mohsen
Position
Assistent professor; Neonatologis
Other areas of specialty/work
Street address
Ganj afrooz street, Ayatollah Rohani hospital
City
Babol
Postal code
Phone
+98 11 3223 8290
Fax
Email
matia.mojaveri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mitra Gorji Rad
Position
resident of pediatric
Other areas of specialty/work
Street address
Ganj afrooz street, Aiatollah Rohani Hospital
City
Babol
Postal code
Phone
00
Fax
Email
m.gorjirad@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)