The goal of this study was to evaluate the effect of zinc sulfate in the treatment of jaundice in low birth weight newborns. In a randomized double blind placebo – controlled study, low birth weight infants with the complaint of icter are selected. Study participants receive either zinc sulfate 10 mg BID as per oral for 5 days or placebo twice time/ day for five Dayes. Then they receive phototherapy and their bilirubin level is measured in 12hr, 24hr, 48hr, 72hr, 96hr and 120 hour afterword.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401041162N22
Registration date:2015-07-31, 1394/05/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-31, 1394/05/09
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-05-24, 1393/03/03
Expected recruitment end date
2015-06-18, 1394/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral zinc on hyperbilirubinemia on LBW premature neonates admitted in NICU
Public title
Effect of oral zinc on hyperbilirubinemia on LBW premature neonates admitted in NICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Babies who admitted to NICU of Imam Reza Hospital; birth weight 1500-2500 gm; Exclusion Criteria: jaundice in day one; hemolysis with positive comb’s test; severely ill babies; infection and sepsis based on clinical and lab test; those with ventilator support; five minutes apgar less than 7; congenital anomalies; intolerance of feeding ; intolerance of zinc supplementation ( gastrointestinal hemorrhage and residue, suddenly getting poor general condition) ; and mothers with sing of high or low level of serum zinc
Age
From 2 days old to 28 days old
Gender
Both
Phase
2
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Mashad University of Medical Sciences
Street address
Ghoreshi bilding, Daneshgah street
City
Mashhad
Postal code
Approval date
2014-05-24, 1393/03/03
Ethics committee reference number
922234
Health conditions studied
1
Description of health condition studied
low birth weight
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight
2
Description of health condition studied
hyperbilirubinemia
ICD-10 code
P59.0
ICD-10 code description
Neonatal jaundice associated with preterm delivery
Primary outcomes
1
Description
decreasing of serum bilirubin
Timepoint
befor intervention and 12,24,48,72 , 96 and 120 hours after intervention
Method of measurement
measurment of serum bilirubin (diazo method)
Secondary outcomes
1
Description
tereatment of jaundice of neonate
Timepoint
befor intervention and 24,48,72 , 96 and 120 hours after intervention
Method of measurement
decreasing of jaundice and bilirubin level in blood serum
Intervention groups
1
Description
in cases: zinc sulfate 10 mg BID as per oral for 5 days or placebo twice time/ day
Category
Treatment - Drugs
2
Description
in controls:Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Imam Reza Hospital , Neonatal Research Center
Full name of responsible person
Dr Ashraf Mohammadzadeh
Street address
NRC, NICU, Imam Reza Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Gghoreshi bulding, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Neonatal Research Center
Full name of responsible person
Dr Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC, NICU, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1852 1121
Fax
Email
mohamadzadeha@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC, NICU, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1852 1121
Fax
Email
mohamadzadeha@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC, NICU, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1852 1121
Fax
Email
mohamadzadeha@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)