Objectives: Evaluation of freeze-thawing method in reducing viral load of Cytomegalovirus in the breast milk of preterm infants;
Design: Single arm study,single blind, no placebo. one-centered;
Setting and conduct: The breast milk of 78 mothers with preterm infants who were seropositive for CMV, were included in the study, for assessing CMV viral load with PCR . In positive viral loads of CMV, after freezing the milk for 72 hours and then, thawing it, the CMV viral load will be assessed again with PCR. After 2-3 months CMV viral load will be assessed in infants' urine sample by PCR.
Major Inclusion criteria: immune mothers to CMV with preterm infants (under 32 weeks) or low birth weight (below 2000 grams);
Major Exclusion criteria: Seronegative mothers (IgG-,IgM-);
Sample size: 78;
Intervention duration: 1 year
Intervention: freezing the infected milk with CMV for 72 hours and thawing it before consumption
main outcome variables: Assessing CMV viral load in the milk of mothers with preterm infants; Comparing the viral load between the milk of mothers with preterm infants before and after freezing
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310164113N6
Registration date:2015-10-05, 1394/07/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-05, 1394/07/13
Registrant information
Name
Mohammad Bagher Hosseini
Name of organization / entity
Tabriz Universisty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
hossainm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-06-01, 1394/03/11
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of freeze-thawing method in reducing viral load of Cytomegalovirus in the breast milk of preterm infants.
Public title
Evaluation of freezing - thawing method in reducing the CMV(Cytomegalovirus) Viral load in the breast milk of mothers with preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: mothers with preterm infants (under 32 weeks) or low birth weight (below 2000 grams); Mothers who are immune to CMV (IgG+,IgM-); Mothers with acute CMV infection, based on serologic findings (IgG+,IgM+)
Exclusion criteria: mothers with infants more than 2000 grams or more than 32 weeks of gestation; Seronegative mothers (IgG-,IgM-)
Age
From 1 day old to 3 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research and technology deputy, third floor, central building number 2, Tabriz University of Medical Sciences,Golgasht street
City
Tabriz
Postal code
Approval date
2015-05-25, 1394/03/04
Ethics committee reference number
tbzmed.rec.1394.165
Health conditions studied
1
Description of health condition studied
Cytomegalovirus
ICD-10 code
B25.9
ICD-10 code description
Cytomegaloviral disease, unspecified
Primary outcomes
1
Description
The Cytomegalovirus l load in milk
Timepoint
Before and after 72 hours of freezing in -20 degree of Celcius
Method of measurement
Using real time PCR(copies/mL)
Secondary outcomes
1
Description
Cytomegalovirus load in infant blood
Timepoint
2 -3 months of age in infants
Method of measurement
Assessing infants' urine samples with real time PCR
Intervention groups
1
Description
Control group: We couldn't choose a control group because of ethical limitations of finding CMV virus in the breast milk of the mothers with preterm infants and not doing any interventions such as freezing.
Category
Prevention
2
Description
Intervention group: Freezing the breast milk at -20°C for 72 hours and then thawing it in refrigerator
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra teaching hospital of Tabriz
Full name of responsible person
Mohammad Bagher Hosseini
Street address
Alzahra teaching hospital, Baghshomal intersect, Artesh street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Hosseini
Street address
Central building of Tabriz University of Medical Sciences, Golgasht street, Azadi street
City
Tabriz
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, Tabriz 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
Pediatric Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Hosseini MD
Position
Associate professor in Neonatology
Other areas of specialty/work
Street address
Pediatric health Research center, Children hospital, Sheshgelan street, Abbasy Ave
City
Tabriz
Postal code
Phone
+98 41 3526 2265
Fax
Email
hossainm@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pediatric Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Hosseini MD
Position
Associate Professor of Neonatology
Other areas of specialty/work
Street address
Pediatric health Research center, Children hospital, Sheshgelan street, Abbasy Ave
City
Tabriz
Postal code
Phone
+98 41 3526 2265
Fax
Email
hosseini.neo@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pediatric Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Hosseini MD
Position
Associate Professor of Neonatology
Other areas of specialty/work
Street address
Pediatric health Research center, Children hospital, Sheshgelan street, Abbasy Ave
City
Tabriz
Postal code
Phone
+98 41 3526 2265
Fax
Email
hosseini.neo@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)