Comparison of the use of plastic caps with cotton caps in the delivery room to prevent hypothermia in very premature infants in the special care department of Imam Khomeini Hospital.
Design
A clinical trial with a control group , randomization as Parallel two groups (intervention group and control group) and two block permuted (for each group two blocks of 28-32 weeks and 25-27 weeks), randomization by the list of numbers generated by the computer in closed envelopes and seen by the relevant resident and placing the baby in the relevant group
Settings and conduct
Placement of infants born less than 32 weeks in the maternity hospital or the operating room of Imam Khomeini Teaching Hospital in Sari in two intervention groups receiving plastic caps and the control group receiving fabric caps.
Participants/Inclusion and exclusion criteria
Entry requirements: All infants less than 32 weeks
Conditions of non-entry: Congenital anomalies ، Congenital problems characterized by defects in the skin ، infants who do not need to start resuscitation according to the newborn resuscitation guidelines, including infants under 22 weeks , weight under 400 grams, anencephalic infants, infants with life-threatening anomalies diagnosed by a doctor ، infants born to mothers with covid-19 ، LGA, IUGR, SGA babies according to the pregnancy ultrasound report or based on the weight-for-gestational age curve Premature infants ، infants 24 weeks and less ، infants who need phototherapy at the beginning of hospitalization.
Intervention groups
The use of plastic caps in 34 premature infants 25 to 32 weeks in the intervention group and the use of cloth caps in 34 premature infants 25 to 32 weeks in the control group to prevent hypothermia
Main outcome variables
hypothermia during hospitalization and post stabilization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091201002801N5
Registration date:2023-02-09, 1401/11/20
Registration timing:prospective
Last update:2023-02-09, 1401/11/20
Update count:0
Registration date
2023-02-09, 1401/11/20
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
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the use of plastic caps with cotton caps in the delivery room to prevent hypothermia in extremely & very premature infants
Public title
Comparison of the use of plastic caps with cotton caps in the delivery room to prevent hypothermia in extremely & very premature infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All infants less than 32 weeks who are born in the maternity hospital or operating room of Imam Khomeini Teaching Hospital in Sari
Exclusion criteria:
Congenital anomalies in infants
Congenital problems characterized by defects in the newborn's skin, such as gastroschisis, epidermolysis bullosa, emphalocele, and myelomeningocele
infants who do not need to start resuscitation according to the newborn resuscitation guidelines include infants under 22 weeks, weighing less than 400 grams, anencephalic infants, infants with anomalies contrary to life as diagnosed by a doctor.
infants 24 weeks and less
infants LGA, IUGR, SGA according to pregnancy ultrasound report or based on the weight-for-gestational-age curve of premature infants
infants who need phototherapy at the beginning of hospitalization
infants born to mothers with covid-19
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done just before the delivery of the infant. Randomization is done as parallel two groups (intervention group and control group) and as two block permuted (for each group two blocks of 28-32 weeks and 25-27 weeks) to remove the intervening factor of gestational age. Randomization is created by the list of numbers generated by the computer and placed in sealed envelopes. Right after delivery, the resident is seen in the resuscitation team and the baby is placed in the appropriate group. For multiple births, each child is randomized separately.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
So far, no study has been conducted in the field of covering the head with a plastic cap, especially at a very low gestational age in premature infants of 25 to 32 weeks.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Pasdaran Boulevard, Boali Sina Hospital
City
sari
Province
Mazandaran
Postal code
4815838477
Approval date
2023-02-05, 1401/11/16
Ethics committee reference number
IR.MAZUMS.REC.1401.490
Health conditions studied
1
Description of health condition studied
Hypothermia of newborn
ICD-10 code
P80
ICD-10 code description
Hypothermia of newborn
Primary outcomes
1
Description
Hypothermia at the time of hospitalization and post stabilization
Timepoint
Measurement of axillary temperature of newborns at birth and one hour after hospitalization and stabilization
Method of measurement
mercury thermometer
Secondary outcomes
1
Description
Hospitalization days, presence or absence of death, patent ductus arteriosus, retinopathy of prematurity, intraventricular hemorrhage, sepsis, necrotizing enterocolitis, need for surfactant and duration of respiratory support
Timepoint
During hospitalization
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: infants who receive plastic caps.
Category
Prevention
2
Description
Control group: infants who receive cotton caps.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Roya Farhadi
Street address
Pasdaran Boulevard, Boali Sina Hospital
City
sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3010
Email
rfarhadi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnezhad
Street address
Moalem Ave, Vice President of Research and Technology
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pasdaran Boulevard, Boali Sina Hospital
City
sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3018
Email
rfarhadi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pasdaran Boulevard, Boali Sina Hospital
City
sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Email
rfarhadi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pasdaran Boulevard, Boali Sina Hospital
City
sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Email
rfarhadi@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It will be published later in the form of a controlled clinical trial article.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The information and results of the study are shared in the form of a clinical trial article.
When the data will become available and for how long
After finishing the research project in the form of an article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In the form of a scientific article
From where data/document is obtainable
A magazine that will be published later
What processes are involved for a request to access data/document