Through this randomized clinical trial, 100 neonates admitted with jaundice in neonates wards of Kashan hospitals in 2013, will be studied. Inclusion criteria included: gestational age > 38 weeks; age > 24 hours on admission; serum level of total bilirubin > 15 mg/dl; indirect hyperbilirubinemia. Exclusion criteria included: necessery to fluid therapy except icter; preterm and LBW neonates; hemolytic jaundice; sepsis; prolonged icter. Patients randomly assign into two groups (intervention or control). control group (N=50 cases) receiving only phototherapy but intervention group (N=50 cases) receiving intravenous fluid plus phototherapy. Intravenous fluids containing dextrose 10% equal amounts of maintenance with 30 mEq/L sodium and 20 mEq/L potassium. Total and indirect bilirubin levels will be measured in two groups at admission and 6, 12, 24 hours after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022711145N5
Registration date:2013-03-26, 1392/01/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-26, 1392/01/06
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intravenous Fluid therapy on Serum level of Bilirubin in icteric neonates during phototherapy
Public title
Effect of Intravenous Fluid therapy on Serum level of Bilirubin in icteric neonates during phototherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age > 38 weeks; age > 24 hours on admission; serum level of total bilirubin > 15 mg/dl; indirect hyperbilirubinemia
Exclusion criteria: Necessery to fluid therapy except icter; preterm and LBW neonates; hemolytic jaundice; sepsis; prolonged icter
Age
From 1 year old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th Kilometer, Ghotbe Ravandi Bulv, Kashan
City
Kashan
Postal code
8715988141
Approval date
2013-03-12, 1391/12/22
Ethics committee reference number
پ/4638/1/5/29
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.
ICD-10 code description
Neonatal jaundice due to unspecified causes
Primary outcomes
1
Description
Serum bilirubin level
Timepoint
on admission, 6-12-24 hours later
Method of measurement
Blood test
Secondary outcomes
1
Description
Duration of phototherapy
Timepoint
During hospitalization
Method of measurement
Calculating the hours of phototherapy
Intervention groups
1
Description
Control: only phototherapy without intravenous fluid
Category
Treatment - Drugs
2
Description
Intervention: Intravenous fluids containing dextrose 10% equal amounts of maintenance with 30 mEq/L sodium and 20 mEq/L potassium plus phototherapy