The purpose of this randomized clinical trial is to investigate the effect of Zipkif plastic bag in prevention of hypothermia in preterm newborns. The group of study is all preterm newborns less than 32nd gestational week. Dead or newborns with congenital anomaly are excluded. The intervention under study is wrapping in Zipkif plastic bag. The newborns in the intervention group will put in bags sized 40 x 25 Cm immediately after delivery. In control group, newborns will resuscitate with conventional method and will dry with warm towel immediately after delivery. At the end of resuscitation, at the time of admission of newborns, and 1 hour after it axillaries temperature is measured as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809162801N1
Registration date:2010-11-07, 1389/08/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-07, 1389/08/16
Registrant information
Name
Roya Farhadi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 3018
Email address
rfarhadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Science
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Zipkif plastic bag on prevention of hypothermia in preterm newborns
Public title
Effect of wrapping of preterm newborns in plastic bag on prevention of hypothermia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: preterm newborns below 32 weeks who born alive
Exclusion criteria: congenital anomaly, open neural tube defect, skin lesions & epidermolysis bullosa, abdominal wall defect (omphalocel & gastrochesis), newborns less than 23 weeks or less than 400grams, newborns of febrile mothers
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University Of Medical Sciences
Street address
Vice chancellor research, Mazandaran University of Medical Sciences, Moallem street, Sari
City
Sari
Postal code
4817844718
Approval date
2010-09-30, 1389/07/08
Ethics committee reference number
89-86
Health conditions studied
1
Description of health condition studied
Neonatal hypothermia
ICD-10 code
P80
ICD-10 code description
Hypothermia of newborn
Primary outcomes
1
Description
Hypothermia
Timepoint
Immediately & 1 hour after intervention
Method of measurement
by digital thermometer & definition is axillary temperature of <36 degree centigrade
Secondary outcomes
1
Description
Intra Ventricular Hemorrhage
Timepoint
3 days after intervention
Method of measurement
Brain Sonography
2
Description
Mortality during first 3 days
Timepoint
first 3 days after intervention
Method of measurement
observation
3
Description
Saturation pressure of Oxygen
Timepoint
Immediately after intervention
Method of measurement
Pulse -Oxymeter
4
Description
Duration of resuscitation
Timepoint
Immediately after intervention
Method of measurement
By cronometer in seconds
5
Description
Hypoglycemia
Timepoint
1&3 hours after intervention
Method of measurement
by Glocometer
6
Description
Hyperthermia
Timepoint
Immediately after intervention &1 hour after intervention
Method of measurement
by digital thermometer has been defined >37.5 degree of centigrade
Intervention groups
1
Description
Wrapping of newborns in zipkif plastic bag without drying under warmer after delivery
Category
Prevention
2
Description
Newborns are conventionally dried under the warmer
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Roya Farhadi
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor research, Mazandaran University of Medical Sciences, Moallem street, Sari
City
Sari
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, Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Assistant Professor, Neonatologist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Sari
City
Sari
Postal code
48166-33131
Phone
+98 151226117004
Fax
Email
dr_royafarhadi@yahoo.comrfarhadi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Assistant professor, Neonatologist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Sari
City
Sari
Postal code
48166-33131
Phone
+98 15122617004
Fax
Email
dr_royafarhadi@yahoo.comrfarhadi@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Assistant Professor, Neonatologist
Other areas of specialty/work
Street address
Imam KHomeini Hospital, Sari
City
Sari
Postal code
48166-33131
Phone
+98 15 1226 1700
Fax
Email
dr_royafarhadi@yahoo.comrfarhadi@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)