Protocol summary

Summary
Hyponatremia (Serum Sodium less than 130mEq/L) is a relatively common electrolyte disturbance among neonates admitted to NICU receiving routine 0.2 Saline solution as maintenance therapy. This condition is caused by one of the three general mechanisms: 1) an inability to excrete water load. 2) Excessive sodium loss. 3) Inadequate sodium intake. One common etiology in the neonatal period is the negative balance of sodium due to low sodium intake and excessive sodium loss because of the high fractional excretion of sodium. Several studies have shown that hyponatremia is associated with poor neurologic outcome later in life. In order to prevent this complication, in this clinical trial, sixty neonates with gestational age of 38-42 weeks with the diagnosis of neonatal sepsis will be enrolled. Patients will be divided into two groups of intervention and control, 30 patients each, based on computerized randomization. First group (case group) will receive IV fluid with 75 mEq/L of sodium (half-saline) as maintenance whereas second group (control group) will be treated with the routine 0.2 Saline (30 mEq/L of sodium). Serum Sodium, Potassium, Creatinine, BUN, Osmolality, Urine osmolality, urine volume will be measured before initiation of therapy and at defined intervals of 6, 12, 24, 48 hours. The prevalence of dysnatremia will then be compared in two groups. Exclusion criteria are congenital heart disease, renal disease, dehydration, dysnatremia, hyperbilirubinemia.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017053034223N1
Registration date: 2017-10-12, 1396/07/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-12, 1396/07/20
Registrant information
Name
Hani Milani
Name of organization / entity
AliAsghar Children Hospital, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21222220415
Email address
hanimilani@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Incidence of dysnatremia during maintenance intravenous fluid therapy in term neonates with sepsis: A prospective randomized study comparing half-saline and standard 0.2 saline solutions
Public title
Comparing the prevalence of dysnatremia between two methods of intravenous fluid therapy, Half-saline and the conventional 0.2 saline solutions in term neonates
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Term neonates of 38-42 weeks gestation and more than 3 days old admitted with the diagnosis of neonatal sepsis Exclusion criteria: Congenital heart disease; Renal disease; Severe dehydration; dysnatremia; Hyperbilirubinemia
Age
From 3 days old to 31 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
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
Iran University of Medical Sciences
Street address
Vice-presidency for Research and Technology,Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
1395.9411403002

Health conditions studied

1

Description of health condition studied
Bacterial sepsis of newborn
ICD-10 code
P36
ICD-10 code description
Bacterial sepsis of newborn

Primary outcomes

1

Description
Serum Sodium
Timepoint
Before intervention and at hours 6, 12, 24, 48
Method of measurement
Venous Blood Sample, mEq/L

Secondary outcomes

1

Description
urine Osmolarity
Timepoint
Before intervention and at hours 12, 24, 48
Method of measurement
mOsmol/L

2

Description
Serum Potassium
Timepoint
Before intervention and at hours 6, 12, 24, 48
Method of measurement
Blood Sampling, mEq/L

3

Description
Serum Creatinine
Timepoint
Before intervention and at hours 6, 12, 24, 48
Method of measurement
Blood Sampling, mg/dL

4

Description
BUN
Timepoint
Before intervention and at hours 6, 12, 24, 48
Method of measurement
Blood Sampling, mg/dL

5

Description
Urinary output
Timepoint
Before intervention and at hours 24, 48
Method of measurement
ml

Intervention groups

1

Description
Intervention: Using Half-saline solution (75 mEq/L of sodium) as maintenance IV fluid
Category
Treatment - Other

2

Description
Control: Using conventional 0.2 saline solution ( 30 mEq/L of sodium) as maintenance IV fluid
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Aliasghar Children Hospital
Full name of responsible person
Hani Milani
Street address
Zafar St., Modarres Highway
City
Tehran

2

Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Hani Milani
Street address
Bagh Ferdos station, Molavi St.,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Mousavi
Street address
Vice presidency of Research and Technology, Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hani Milani
Position
Neonatology Fellow
Other areas of specialty/work
Street address
Zafar St., Modarres Highway,
City
Tehran
Postal code
Phone
+98 21 2304 6215
Fax
Email
hanimilani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hani Milani
Position
Neonatology Fellow
Other areas of specialty/work
Street address
Zafar St., Modarres Highway,
City
Tehran
Postal code
Phone
+98 21 2304 6215
Fax
Email
hanimilani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hani MIlani
Position
Neonatology Fellow
Other areas of specialty/work
Street address
Zafar St., Modarres Highway,
City
Tehran
Postal code
Phone
+98 21 2304 6215
Fax
Email
hanimilani@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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