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Comparing the effects of conventional care and Kangaroo Mother Care on duration of hospitalization, ‎weight gain, exclusive breastfeeding, and physiological measures in low birth weight ‎neonates in intensive care unit

Protocol summary

Summary
Low birth weight significantly associated with infant mortality rate. Neonates in neonatal intensive care wards are separated from the mothers and lack of parental ‎participation in care, have many risks and threats. Kangaroo Mother Care(KMC) is identified as ‎alternative methods of care that can help to reduce these risks and threats. Kmc method cause ‎better communication of parents and infants, improve weight gain in preterm infants, early ‎discharge, reduction of nosocomial infection, develop exclusive breastfeeding, reduce hospital ‎costs, cause more parental participation in care and better infant growth and development . Methods: This study was a semi-experimental clinical trial in which a researcher examine effects ‎of independent variables (kmc care, Incubator care) on the dependent variables (body ‎temperature, weight gain, exclusive breastfeeding, physiological measures) in 130 low birth ‎weight infants admitted to neonatal intensive care in Tehran Mahdieh hospital ( 2009-2010). Since the success of kmc implementation and follow-up for the proper function ‎and protection of mothers related to doctors and personnel knowledge and experience, the ‎importance and necessity of training courses in this respect is obvious.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010204982N1
Registration date: 2011-01-31, 1389/11/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-01-31, 1389/11/11
Registrant information
Name
Soheila Khazaei
Name of organization / entity
Ministry of health and medical education
Country
Iran (Islamic Republic of)
Phone
+98 21 7765 0780
Email address
khazaei@health.gov.ir
Recruitment status
Recruitment complete
Funding source
researcher
Expected recruitment start date
2009-06-02, 1388/03/12
Expected recruitment end date
2011-03-02, 1389/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of conventional care and Kangaroo Mother Care on duration of hospitalization, ‎weight gain, exclusive breastfeeding, and physiological measures in low birth weight ‎neonates in intensive care unit
Public title
Kangaroo care in premature neonates
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1. without ‎congenital anomalies 2. Birth weight between 2499-1200 grams. 3. fifth minute Apgar score is ‎six and higher. 4. not having respirator care in the past 12 hours 5. not used umbilical arterial ‎catheter 6. not used Photo therapy in previous 4 hours ago 7. the baby's body temperature is ‎not unstable. 8. 8 hours out of the endotracheal tube 9. not having chest tube 10. not having ‎symptoms of respiratory distress .For mothers of neonates, inclusion criteria were : 1- familiar ‎with Persian language. 2- not having malignant disease and fever 3- not having addiction and smoking ‎‎– 4- not having AIDS and acute respiratory and heart disease 5- being biological mother. 6- not having ‎convulsions or seizure disorders 7- having self-care ability. ‎ Exclusion criteria: 1-Mother refusing 2-Apnea more than 20 second.
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 130
Randomization (investigator's opinion)
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
Tehran university of medical sciences
Street address
Enghelab street
City
Tehran
Postal code
0098
Approval date
2010-12-11, 1389/09/20
Ethics committee reference number
1115/130/د/89

Health conditions studied

1

Description of health condition studied
Disorders related to short gestation and low birth weight
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants

Primary outcomes

1

Description
Weight gain
Timepoint
DAILY
Method of measurement
scale

2

Description
Body temprature
Timepoint
During daily kangaroo mother care
Method of measurement
Termometr

3

Description
Infection
Timepoint
According to sign and symptom
Method of measurement
Laboratory

4

Description
Exclusive breast feeding
Timepoint
Persistant
Method of measurement
Look

5

Description
Respiratory problems
Timepoint
All of the time of care
Method of measurement
Palsoximetry

6

Description
Pulse rate
Timepoint
During kangaroo care
Method of measurement
control Machine

Secondary outcomes

1

Description
Hospitalisation days
Timepoint
After releasing
Method of measurement
Days number

Intervention groups

1

Description
kangaroo care or KMC
Category
Prevention

2

Description
Incubator care
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr.Saree
Street address
Enghelab street
City
Tehran
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, Tehran 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
Ministry of health and medical education
Full name of responsible person
Dr.Soheila Khazaei
Position
associate professor
Other areas of specialty/work
Street address
Children office, Center for Network Development and Health promotion, Ministry of Health and Medical Education (MOHME), Hafez Street
City
Tehran
Postal code
1134845768
Phone
+98 21 7763 3499
Fax
Email
khazaei@health.gov.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ministry of Health and Medical Education (MOHME)
Full name of responsible person
Dr Soheila Khazaei
Position
associate professor
Other areas of specialty/work
Street address
Children office, Center for Network Development and Health promotion, Ministry of Health and Medical Education (MOHME), Hafez Street
City
Tehran
Postal code
Phone
+98 21 7763 3499
Fax
Email
khazaei@health.gov.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Soheila Khazaei
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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