The aim of this study was to determine the impact of Alhagi pseudalhagi on neonatal hyperbilirubinemia. This study was a clinical trial performed on term neonates with non hemolytic indirect hyperbilirubinemia. A total of 124 patients were assigned into one of following groups. In the first group, the mother and neonate received Alhagi pseudalhagi 25% cocentration solution, 30 cc and 1cc/kg, respectively, every 8 hours. In the two other groups, either mother or neonate received the solution with the above-mentioned dosage. In the control group, neither mother nor neonate received the solution. The neonates in all groups received phototherapy and the interventions were continued until the serum level of bilirubin decreased to the normal level. The serum level of bilirubin was measured at the baseline and after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012042085N6
Registration date:2011-01-20, 1389/10/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-20, 1389/10/30
Registrant information
Name
Neda Parvin
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
nedali285@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of Alhagi pseudalhagi effect on blood bilirubin in neonates with hyperbilirubinemia in Shahrekord Hajar hospital
Public title
Survey of Alhagi pseudalhagi effect on blood bilirubin in neonates with hyperbilirubinemia in Shahrekord Hajar hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Signing informed consent by parents, total serum bilirubin between 14 and 20 mg/dL, presence of Non hemolytic hyperbilirubinemia, presence of indirect hyperbilirubinemia, hyperbilirubinemia which starts between the third and tenth days after birth, term infant, (Gestational age 42-37 weeks), birth weight 4-5/2 Kg, exclusive breast feeding, Ability of mother to attend the neonate’s bedside, no congenital anomaly, no sepsis, history of asphyxia, or traumatic delivery, no cephalohematoma, no history of neonatal jaundice, no previous treatment for jaundice, any other treatments or hospitalization, no other treatment with antibiotic or other drugs
Exclusion criteria: discharge for any reason before bilirubin less than 12mg/dl, need to other drugs during treatment
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2009-02-20, 1387/12/02
Ethics committee reference number
2-12-1387
Health conditions studied
1
Description of health condition studied
hyperbilirubinemia
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Serum level of bilirubin
Timepoint
Baseline and then daily during the study
Method of measurement
blood sample
Secondary outcomes
1
Description
hospital stay
Timepoint
During hospital stay
Method of measurement
The number of days that neonate is hospitalized
Intervention groups
1
Description
The mother and neonate received Alhagi pseudalhagi 25% cocentration solution, 30 cc and 1cc/kg, respectively, every 8 hours as well as phototherapy until the serum level of bilirubin decreased to the normal level.
Category
Treatment - Drugs
2
Description
The mother only received Alhagi pseudalhagi 25% cocentration solution, 30 cc every 8 hours as well as phototherapy for the neonates until the serum level of bilirubin decreased to the normal level.
Category
Treatment - Drugs
3
Description
In the control group, neither mother nor neonate received the solution. The neonates only received phototherapy until the serum level of bilirubin decreased to the normal level.
Category
Treatment - Other
4
Description
The neonate only received Alhagi pseudalhagi 25% cocentration solution, 1 cc/kg, every 8 hours as well as phototherapy until the serum level of bilirubin decreased to the normal level.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Hajar Hospital
Full name of responsible person
Neda Parvin
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Neda Parvin
Street address
Shahrekord University Of Medical Sciences
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Neda Parvin
Position
MS
Other areas of specialty/work
Street address
Shahrekord University Of Medical Sciences
City
Shahrekord University Of Medical Sciences
Postal code
Phone
+98 38 1334 6692
Fax
Email
np285@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Neda Parvin
Position
MS Nursing
Other areas of specialty/work
Street address
Shahrekord University Of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1334 6692
Fax
Email
np285@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)