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Effect of kangaroo mother care on premature infants’s physiological indices and breastfeeding

Protocol summary

Summary
The aim of this study was to determine the effect of kangaroo mother care on premature infants’ physiological indices and breastfeeding in the Fatemieh Hospital in Hamadan in 2015. A semi-experimental study will conduct among 100 premature neonates with gestational age between 32-36 weeks and weight less than 2500 grams. Infants who those mothers intend to kangreoo mother care (KMC) and stay in hospital will allocate in the intervention group. Mothers who do not intend to KMC and do not stay in hospital will allocate in the Control group. Two groups will match based on gestational age and weight. The infant in the intervention group receive KMC every day at least half an hour for four times. Physiological indices such as weight gain body temperature, oxygen saturation, pulse rate, respiratory rate, number of breastfeeding, infection, and length of hospitalization will assess daily. The infant in control group receive only routine care within the incubator and they will not remove from incubator except for feeding. In this group physiological indicators such as weight gain body temperature, oxygen saturation, pulse rate, respiratory rate, number of breastfeeding, infection, and length of hospitalization will assess three times in a day. Finally, two groups will compare from neonatal admission to discharge from hospital.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015030310426N7
Registration date: 2015-04-02, 1394/01/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-04-02, 1394/01/13
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of kangaroo mother care on premature infants’s physiological indices and breastfeeding
Public title
Effect of kangaroo mother care on premature infants’ physiological indices and breastfeeding in the Fatemieh Hospital in Hamadan in 2015
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: low birth weigh; gestational age between 32-36 weeks without any congenital anomaly; stable newborn; physicians' permission to leave from incubator; without undergoing neonatal surgery; without photo-therapy; completed consent form their mother to participate of the study. Exclusion criteria: mother or infant conditions; illness and stressful events during the study such as NCPAP; breastfeeding contraindications.
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences- Shahid Fahmideh Street- Counterpoint of Mardom Park- Hamadan
City
Hamadan
Postal code
65178
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
p/16/35/9/6368

Health conditions studied

1

Description of health condition studied
Disorders related to short gestation and low birth weight, not elsewhere classified
ICD-10 code
P07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.

Primary outcomes

1

Description
Neonatal weight gain
Timepoint
Daily
Method of measurement
Balance Scale

2

Description
Physiological indices
Timepoint
Three times per day
Method of measurement
Termometer, Neonatal Monitoring Device

3

Description
Number of breastfeeding
Timepoint
Daily
Method of measurement
Observation

Secondary outcomes

1

Description
Neonatal infection
Timepoint
Daily
Method of measurement
Based on labratory tests

2

Description
Lenght of hospitalization
Timepoint
Daily
Method of measurement
Observation

Intervention groups

1

Description
The infant in control group receive only routine care within the incubator and they will not remove from incubator except for feeding . In this group physiological indicators such as weight gain body temperature, oxygen saturation, pulse rate, respiratory rate, number of breastfeeding, infection, and length of hospitalization will assess three times in a day. Then, these indicators ob control group will compare with intervention group from neonatal admission to discharge from hospital.
Category
Other

2

Description
The infant in the intervention group receive KMC every day at least half an hour for four times during a day . Physiological indices (such as weight gain body temperature, oxygen saturation, pulse rate, respiratory rate), number of breastfeeding, infection, and length of hospitalization will assess every day. The comparison will done between intervention group and control group from neonatal admission to discharge from hospital.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nonatal Intensive Care Unite (NICU) in Fatemiah Hospital
Full name of responsible person
Dr. Behnaz Basiri
Street address
Fatemieh Hospital of Hamadan, Kermanshah street, Hamadan
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saied Bashirian
Street address
Shahid Fahmideh Street- Counterpoint of Mardom ParkHamadan University of Medical Sciences-
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Asistant Professor / PhD
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178-38698
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medicine and Health Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor/Ph.D
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178-38698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor/ Ph.D
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178-38698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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