In this study which is conducted as a quasi-experimental design, infants older than 34 weeks up to 41 weeks and 6 days of week with a diagnosis of transient tachypnea of the newborn were enrolled. In the control group, in the first day of life 60ml/kg/d, in the second day 80ml/kg/d and from the third day 100 ml/kg/d of 10% dextrose water were administered. In the intervention group, in the first day 40 ml/kg/d, in the second day 60 ml/kg/d and from the third day of life 80 ml/kg/d of10% dextrose water were prescribed. In cases who were cared under radiant warmer 20 ml per kg is added to the solution volume. The hours of oxygen requirement, the hours of NCPAP requirement and the hours of mechanical ventilation requirement and duration of hospitalization are recorded. inclusion criteria: tachypnoea (RR>60); standing on tachypnea at least for 12 hrs; feature of CXR at least for one of these: prominent pulmonary hilus, increase thickness of lobar fisher due to accumulation of fluid, hilar congestion of both lung, flattening of diaphragm,increase AP diameter of chest exclusion criteria:neonate with congenital anomaly; systemic sepsis; mecunium aspiration; RDS; IUGR; fetal distress history; pneomonitis; congenital heart disease; DIC; multi organ failure; hypocalcemia; hypoglycemia; polycytemia; Na>150; Bun>20; K>5; Bill>15; urine out put<1cc/kg/hr
General information
Acronym
TTN
IRCT registration information
IRCT registration number:IRCT2012111111432N1
Registration date:2013-08-23, 1392/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-23, 1392/06/01
Registrant information
Name
Anahita Ghaemaghami
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1443 2779
Email address
ghaemaghami.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz,Jundishapur University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ٍEffect of restrictive fluid management on the outcome of transient tachypnea of the newborn at ahvaz Imam Khomeini hospital
Public title
ٍEffect of restrictive fluid management on the outcome of transient tachypnea of the newborn at ahvaz Imam Khomeini hospital
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: neonate with in 34-0/7to 41-6/7 weeks age with: tachypnoea (RR>60) ;standing on tachypnea at least for 12 hrs; feature of CXR at least for one of these: prominent pulmonary hilus, increase thickness of lobar fisher due to accumulation of fluid, hilar congestion of both lung,flattening of diaphragm,increase AP diameter of chest exclusion criteria:neonate with congenital anomaly;systemic sepsis; mecunium aspiration; RDS; IUGR; fetal distress history; pneomonitis;congenital heart disease; DIC; multi organ failure; hypocalcemia; hypoglycemia; polycytemia; Na>150; Bun>20; K>5; Bill>15; urine out put<1cc/kg/hr
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AHVAZ ,JUNDISHAPUR UNIVERSITY OF MEDICINE SCIENCES
Street address
ahvaz,golestan Blvd.
City
ahvaz
Postal code
Approval date
2012-07-21, 1391/04/31
Ethics committee reference number
ETH-596
Health conditions studied
1
Description of health condition studied
transient tachypnea of the newborn
ICD-10 code
p22.1
ICD-10 code description
Respiratory distress of newborn
Primary outcomes
1
Description
duration of oxygen requirement
Timepoint
during intervention
Method of measurement
hours
2
Description
duration of CPAP requirement
Timepoint
during intervention
Method of measurement
hours
3
Description
duration of VENTILATOR requirement
Timepoint
during intervention
Method of measurement
hours
4
Description
hospitalized duration
Timepoint
during intervention
Method of measurement
days
Secondary outcomes
1
Description
urine out put
Timepoint
during intervention
Method of measurement
cc/kg/hr
2
Description
serum BUN , CREATININ
Timepoint
during intervention
Method of measurement
serum sampling
3
Description
serum K , Na
Timepoint
during intervention
Method of measurement
serum sampling
4
Description
serum bilirubin
Timepoint
during intervention
Method of measurement
serum sampling
5
Description
specific gravity of urine
Timepoint
during intervention
Method of measurement
with refractometer
6
Description
ABG
Timepoint
during intervention
Method of measurement
artery sampling
Intervention groups
1
Description
In the control group, in the first day of life 60ml/kg/d, in the second day 80ml/kg/d and from the third day 100 ml/kg/d of 10% dextrose water were administered. In cases who were cared under radiant warmer 20 ml per kg is added to the solution volume.
Category
Treatment - Other
2
Description
In the intervention group, in the first day of life 40ml/kg/d, in the second day 60ml/kg/d and from the third day 80 ml/kg/d of 10% dextrose water were administered. In cases who were cared under radiant warmer 20 ml per kg is added to the solution volume.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz, Imam Khomeini hospital
Full name of responsible person
Masud Dehdashtian MD.
Street address
Ahvaz, Azadegan ave.,Imam Khomeini hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz,Jundishapur University of Medical Siences
Full name of responsible person
Masud Dehdashtian MD.
Street address
Ahvaz,Imam Khomeini hospital,NICU ward
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?