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Effect of Intravenous Fluid therapy on decreasing serum bilirubin during intensive phototherapy in healthy term neonate with severe non hemolytic hyperbilirubinemia in comparison with phototherapy alone

Protocol summary

Summary
In this survey, the aim of study is comparing the effect of combined fluid therapy and phototherapy with the effect of phototherapy alone in treating the icteric neonates. Healthy term neonates with total bilirubin level more than 17 and less than 25 were included in our study. Neonates with any of these criteria were excluded from the study: prematurity, any systemic diseases or abnormalities, need to blood exchange, weight less than 2500 or more than 4000g and weight loss more than 3% in first ten days of life. This was a prospective clinical trial study. One hundred and sixty breast-fed neonates with hyperbilirubinemia who were admitted to neonatal ward of Besat Hospital (Hamedan, Iran (were divided randomly (alternately) into two groups of intervention and control. Eighty neonates received combination of 70cc/kg /day of ⅓⅔ serum (⅓N/S and ⅔D5W, Tehran-Darou serum Co., Tehran, Iran) and phototherapy (intervention group) and 80 neonates received phototherapy alone (control group). Mean serum bilirubin level was measured 6, 12, 24, 48, and 72 hours after the start of phototherapy and the duration of phototherapy was written in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012295497N1
Registration date: 2013-01-12, 1391/10/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-12, 1391/10/23
Registrant information
Name
Abbas Moein
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0050
Email address
a.moein@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences and Health Services
Expected recruitment start date
2011-06-01, 1390/03/11
Expected recruitment end date
2012-06-01, 1391/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intravenous Fluid therapy on decreasing serum bilirubin during intensive phototherapy in healthy term neonate with severe non hemolytic hyperbilirubinemia in comparison with phototherapy alone
Public title
Assessing the effect of serum therapy on decreasing of icterus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.Term neonate (between 37 and 42 weeks of neonatal age ). 2. All neonates between 2 and 28 days of old age 3. 17< total serum bilirubin <25 . 4. 2500 g < weight< 4000 g 5. Without congenital anomaly and systemic diseases (sepsis, anemia, hemolysis, HMD). Exclusion criteria: 1. Neonate <37 weeks of old age 2. Congenital anomaly, systemic disease (sepsis, HMD. pneumonia, anemia, hemolysis) 3.Demand to blood exchange 4. 4000 g <Weight< 2500 g . 5. Neonates who in first ten days of life loss more than 3% of weight.
Age
From 2 years old to 28 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 160
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
Ethics committee of Hamedan University of Medical Sciences and Health Services
Street address
Opposite Mardom Park, Shahid Fahmide Ave, Mahdieh Ave, Hamedan
City
Hamedan
Postal code
Approval date
2011-05-14, 1390/02/24
Ethics committee reference number
2075/35/16/د/پ

Health conditions studied

1

Description of health condition studied
Neonatal jaundice
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and un specified causes

Primary outcomes

1

Description
Indirect bilirubin
Timepoint
During at 6, 12, 24, 48 and 72 hours after beginning of phototherapy
Method of measurement
Measuring serum bilirubin(diazo method)

Secondary outcomes

1

Description
Age
Timepoint
Between 2 and 28 days of old age
Method of measurement
Since birthday

2

Description
Duration of hospitalization
Timepoint
6- 12- 24- 48 and 72 hours after phototherapy
Method of measurement
Hours

3

Description
Sex
Timepoint
Beginning of study
Method of measurement
Physical examination

4

Description
Blood group
Timepoint
Beginning of study
Method of measurement
Laboratory test

Intervention groups

1

Description
One hundred sixty neonates with hyperbilirubinemia who were admitted at neonate ward of Besat hospital of Hamedan, Iran and who are breast feeding were divided to two groups. Eighty neonates in intervention group receive 70 cc per kg of ⅓-⅔serum daily with phototherapy (together) . The serum that was used, contains sodium as ⅓of normal saline and glucose as of ⅔dextrose 5% and use this serum intravenous until total bilirubin being less than 17. This serum made in Tehran Darou Company.
Category
Treatment - Other

2

Description
One hundred sixty neonates with hyperbilirubinemia who were admitted at neonate ward of Besat hospital of Hamedan, Iran and who are breast feeding were divided to two groups. Eighty neonates (control) receive only phototherapy alone.
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Abbas Moein
Street address
Hamedan Besat Hospital
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Dr Mohammad Alikhani
Street address
Opposite Mardom Park, Shahid Fahmide Ave, Mahdieh Ave, Hamedan
City
Hamedan
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, Hamedan University of Medical Sciences and Health Services
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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moein
Position
Resident
Other areas of specialty/work
Street address
Hamedan Besat Hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0050
Fax
Email
a.moein@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moein
Position
Resident
Other areas of specialty/work
Street address
Hamedan Besat Hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0050
Fax
Email
a.moein@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moein
Position
Resident
Other areas of specialty/work
Street address
Besat Hospital
City
Hamedan
Postal code
Phone
Fax
Email
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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