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Recruitment centers
#1
Name of recruitment center - English: Alzahra Hospital
Name of recruitment center - Persian: بیمارستان الزهرا (س)
Full name of responsible person - English: Sevil Hakimi
Full name of responsible person - Persian: سویل حکیمی
Street address - English: Alzahra Hospital, South Artesh St.
Street address - Persian: خیابان ارتش جنوبی- بیمارستان الزهرا(س)
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 3553 9161
Fax:
Email: mahboubeh.jamehdar@yahoo.com
Web page address:
Name of recruitment center - English: Khalij e Fars Hospital, Bandar Abbas
Name of recruitment center - Persian: بیمارستان خلیج فارس بندرعباس
Full name of responsible person - English: Sevil Hakimi
Full name of responsible person - Persian: سویل حکیمی
Street address - English: Azad University st
Street address - Persian: خیابان دانشگاه آزاد
City - English: Bandar Abbas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7919783141
Phone: +98 76 3367 0280
Fax:
Email: mahboubeh.jamehdar@yahoo.com
Web page address:
Name of recruitment center - English: AlzahraKhalij e Fars Hospital, Bandar Abbas Name of recruitment center - Persian: بیمارستان الزهرا (س)خلیج فارس بندرعباس Full name of responsible person - English: Sevil Hakimi Full name of responsible person - Persian: سویل حکیمی Street address - English: Alzahra Hospital, South Artesh St.Azad University st Street address - Persian: خیابان ارتش جنوبی- بیمارستان الزهرا(س)دانشگاه آزاد City - English: TabrizBandar Abbas City - Persian: تبریزبندرعباس Province: East AzarbaijanHormozgan Country: Iran (Islamic Republic of) Postal code: 51386657937919783141 Phone: +98 41 3553 916176 3367 0280 Fax: Email: mahboubeh.jamehdar@yahoo.com Web page address:
#2
Name of recruitment center - English: Taleghani Educational and Medical Center, Tabriz
Name of recruitment center - Persian: مرکز آموزشی-درمانی طالقانی تبریز
Full name of responsible person - English: Sevil Hakimi
Full name of responsible person - Persian: سویل حکیمی
Street address - English: Taleqani Hospital, Rah Ahan square,Tabriz
Street address - Persian: تبریز، میدان راه آهن، بیمارستان طالقانی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5197615413
Phone: +98 41 3442 4425
Fax:
Email: mahboubeh.jamehdar@yahoo.com
Web page address:
Name of recruitment center - English: Children's Educational and Medical Center, Bandar Abbas
Name of recruitment center - Persian: مرکز آموزشی-درمانی کودکان بندرعباس
Full name of responsible person - English: Sevil Hakimi
Full name of responsible person - Persian: سویل حکیمی
Street address - English: Golshar Shomali, Emam Khomeini blvd, BANDAR ABBAS
Street address - Persian: بندرعباس- بلوار امام خمینی- گلشهر شمالی
City - English: Bandar Abbas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7777777777
Phone: +98 76 3366 6240
Fax:
Email: mahboubeh.jamehdar@yahoo.com
Web page address:
Name of recruitment center - English: TaleghaniChildren's Educational and Medical Center, TabrizBandar Abbas Name of recruitment center - Persian: مرکز آموزشی-درمانی طالقانی تبریزکودکان بندرعباس Full name of responsible person - English: Sevil Hakimi Full name of responsible person - Persian: سویل حکیمی Street address - English: Taleqani HospitalGolshar Shomali, Rah Ahan square,TabrizEmam Khomeini blvd, BANDAR ABBAS Street address - Persian: تبریز، میدان راه آهن، بیمارستان طالقانیبندرعباس- بلوار امام خمینی- گلشهر شمالی City - English: TabrizBandar Abbas City - Persian: تبریزبندرعباس Province: East AzarbaijanHormozgan Country: Iran (Islamic Republic of) Postal code: 51976154137777777777 Phone: +98 41 3442 442576 3366 6240 Fax: Email: mahboubeh.jamehdar@yahoo.com Web page address:
Protocol summary
Study aim
Comparison of neonate nutritional behavior score between two groups on days 1,2,3,4,5 after intervention with baseline score control
Design
Randomized clinical trial with control group, parallel, sample size of 80
Settings and conduct
This study is a randomized controlled clinical trial. After obtaining permission from the Ethics Committee and registration at Iran Clinical Trials Center, the researcher will begin the daily sampling of 80 premature neonates in Alzahra and Taleghani Hospitals through convenience sampling. After evaluating inclusion and exclusion criteria, the goals and methods will be explained to mothers.
Samples will be randomly divided and stratified based on neonate`s age (31-32,6 and 33-35 weeks old) with blocks size 4 , 6 with 1:1 ratio in two groups: intervention group, 3 times of daily care once by mother and twice by surrogate in the last two times of care and the control group 3 times of daily care by mother (up to 5 days each time 60 minutes).Allocation sequences will be determined using RAS. Allocation concealment will be done using opaque-sealed envelopes numbered in sequence and opened by someone other than the researcher. Nutritional behavior will be measured using the Preterm Infant Breastfeeding Behavior Scale and physiological outcomes; temperature will be measured with a thermometer; heart-rate and arterial oxygen saturation will be checked with Pulse-oximeter; respiratory rate will be tested by chest touch and observation once before intervention and once again afterwards for up to 5 days.
Participants/Inclusion and exclusion criteria
31-35 weeks neonates, weighing more than 1500 g and no connection to ventilator
Gravida 1,2
Intervention groups
Intervention: Three times a day of care, once by mother - two times surrogate
Control:Three times a day of mother's care
Main outcome variables
Nutritional behavior score of preterm infant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150424021917N10
Registration date:2020-04-22, 1399/02/03
Registration timing:prospective
Last update:2021-01-21, 1399/11/02
Update count:1
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
Sevil Hakimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hakimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of kangaroo care by mother and surrogate on nutritional behavior of preterm neonates : A randomised controlled clinical trial
Public title
The effect of kangaroo care by mother and surrogate on nutritional behavior of preterm neonates : A randomised controlled clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gravida 1,2
31-35 weeks neonates
Neonate weight more than 1500 g
unfixed female surrogate
Exclusion criteria:
Neonatal sepsis
Neonate connection to ventilator
CPAP use
Catheter in umbilical vein
Prescribing any medication to the neonate that may affect it's sleep
Neonate intra ventricular hemorrhage
Cleft lips and cleft palate
Mother's epilepsy or surrogate
Mother’s or surrogate’s addiction to any drug
New scare in part of mother’s/surrogate’s body that is in direct contact with baby's
Skin rash
Use of perfume and perfume soap
Age
From 217 days old to 245 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly divided and stratified based on neonate`s age (31-32,6 and 33-35 weeks old) with 4 and 6 blocks with 1:1 ratio in two groups: intervention and control groups. Allocation sequences will be determined using RAS. Allocation concealment will be done using opaque-sealed envelopes numbered in sequence and opened by someone other than the researcher.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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 department, Third floor, Central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.TBZMED.REC.1398.1213
Health conditions studied
1
Description of health condition studied
Preterm neonates
ICD-10 code
P07.33
ICD-10 code description
Preterm newborn, gestational age 30 completed weeks
Primary outcomes
1
Description
Nutritional behavior of preterm neonate
Timepoint
Once before the intervention and once again after the intervention for up to 5 days
Method of measurement
Using the questionnaire Preterm Infant Breastfeeding Behavior Score (PIBBS)
Secondary outcomes
1
Description
Nutritional effect
Timepoint
once before the intervention and once again after the intervention for up to 5 days
Method of measurement
With using of standard questionnare
2
Description
Physiological function of preterm neonate (heart rate, temperature, respiratory rate and arterial oxygen saturation)
Timepoint
once before the intervention and once again after the intervention for up to 5 days
Method of measurement
temperature will be measured with a thermometer; heart-rate and arterial oxygen saturation will be checked with Pulse-oximeter; respiratory rate will be tested by chest touch and observation.
Intervention groups
1
Description
Intervention group: Mother/surrogate kangroo care, 3 times of daily care once by mother and twice by surrogate in the last two time of care up to 5 days each time 60 minutes
Category
Behavior
2
Description
Control group: 3 times of daily care by mother up to 5 days each time 60 minute
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalij e Fars Hospital, Bandar Abbas
Full name of responsible person
Sevil Hakimi
Street address
Azad University st
City
Bandar Abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3367 0280
Fax
Email
mahboubeh.jamehdar@yahoo.com
2
Recruitment center
Name of recruitment center
Children's Educational and Medical Center, Bandar Abbas
Full name of responsible person
Sevil Hakimi
Street address
Golshar Shomali, Emam Khomeini blvd, BANDAR ABBAS
City
Bandar Abbas
Province
Hormozgan
Postal code
7777777777
Phone
+98 76 3366 6240
Email
mahboubeh.jamehdar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Samiei
Street address
Research department, Third floor, Central construction, Number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
hakimis@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahboubeh Jamehdar
Position
MSc student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
South Shariati Street, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
mahboubeh.jamehdar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Shariati Street, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
hakimis@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Shariati Street, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
hakimis@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
The results of clinical study will be published as article.
When the data will become available and for how long
Start publishing period 6 months after printing results.
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
Sevil Hakimi hakimis@tbzmed.ac.ir
What processes are involved for a request to access data/document
The applicant sends an application via e-mail. After receiving the email, the results will be sent.