The aim of this study was to determine the prophylactic effect of zinc sulfate in very low birth weight (birth weight < 1500 gm) infants' hyperbilirubinemia. In a randomized double blind clinical trial 60 very low birth weight infants will elect. Those babies who will admit to NICU as including and infants with 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 such as gastrointestinal hemorrhage and residue, suddenly getting poor general condition and mothers with singe of high or low level of serum zinc will exclude.
Study participants receive 10mg zinc sulfate twice a day from day 2 (zinc sulfate group n=30), the other group will receive sterile water as volume as zinc sulfate (control group n=30) by Orogastric tube. As preterm baby need zinc sulfate as supplement in discharge , zinc sulfate will continue as maintenance dose in case group. Serum bilirubin levels will measure at entrance, day 3, day 5 and day 7. Duration of phototherapy also will record in two groups. Side effects drug will observe by physical exam.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306081162N20
Registration date:2013-07-09, 1392/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-09, 1392/04/18
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 science
Expected recruitment start date
2013-04-17, 1392/01/28
Expected recruitment end date
2014-05-18, 1393/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic Effect of oral zinc on hyperbilirubinemia in premature very low birth weight neonates who admitted in NICU
Public title
Prophylactic Effect of oral zinc on hyperbilirubinemia in premature very low birth weight neonates who admitted in NICU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Babies who admitted to NICU of Imam Reza Hospital; birth weight ≤ 1500 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 years old to 2 years old
Gender
Both
Phase
4
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
2013-05-25, 1392/03/04
Ethics committee reference number
910825
Health conditions studied
1
Description of health condition studied
very low birth weigh hyperbilirubinemia
ICD-10 code
P59.0
ICD-10 code description
Neonatal jaundice associated with preterm delivery
Primary outcomes
1
Description
serum bilirubin
Timepoint
befor intervention, day 3, day 5 and day 7
Method of measurement
measurment of serum bilirubin (diazo method)
Secondary outcomes
1
Description
jaundice
Timepoint
befor intervention,day 3, day 5 and day 7
Method of measurement
decreasing of jaundice
Intervention groups
1
Description
For intervention: 10mg zinc sulfate twice a day since birth and will continue to4000 gr postnatal weight per oral
Category
Treatment - Drugs
2
Description
Foe control: the placebo such as case group which prepared by Pharmacologist
Category
Treatment - Drugs
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)