This is the first study to assess the effectiveness of Kangaroo Mother Care (KMC) for infants of low birth weight < 2500g in Iran. We will monitor the effect of Kangaroo Mother Care (KMC) for less than four hours intervals on the body weight, temperature, blood oxygen saturation, nursing frequency, infection disease and death of low weight newborn in Fatemiey hospital neonatal intensive care during year 2012. If this study shows that KMC with less than four hrs intervals is more effective than KMC care for more than four hrs intervals, this method will find more acceptance in neonatal intensive care and the shortening of space and resources won’t stops the mothers to use this method. We will study 120 low birth weight new born, 60 will be in a group of Kangaromother care. The impact of the duration of the intervention will be evaluated on indicators of weight, body temperature and, daily feeding with milk, the risk of infection and mortality assessment.
General information
Acronym
KMC
IRCT registration information
IRCT registration number:IRCT2012072810420N1
Registration date:2012-12-17, 1391/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-17, 1391/09/27
Registrant information
Name
Shohre Heidari Farah
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0033
Email address
sh.heidari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of duration of Kangaroo mother care (KMC) method on the growth of low birth weight neonate
Public title
Comparison the effect of duration of the method of Kangaroo mother care (KMC) on the growth of low birth weight neonate
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1. neonates with weight less than 2500 grams; 2. condition for exit neonate from the incubator and care by the mother; 3. Neonate has not a congenital anomaly or neuromuscular disorder, neonate does not have surgery and not phototherapy. Exclusion criteria: 1. problems not-related to the care during the study; 2. If the parents of the neonate, for any reason and at any time, desire to withdraw from the study.
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Hamedan University of Medical Sciences
Street address
Shahid Fahmideh street
City
Hamedan
Postal code
65178
Approval date
2012-06-11, 1391/03/22
Ethics committee reference number
1030/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Low birth weight neonate
ICD-10 code
E40-46
ICD-10 code description
Malnutrition
Primary outcomes
1
Description
Breast Feeding
Timepoint
1st, 2nd, 5th, 7th days
Method of measurement
Observation
2
Description
Weight gain
Timepoint
1st, 3rd, 5th and 7th days
Method of measurement
weighting scale
3
Description
chanhe in temperature
Timepoint
1st day, 3rd day, 5th day
Method of measurement
termometer
Secondary outcomes
1
Description
The length of inpatient hospitalization
Timepoint
1 month after hospitalization
Method of measurement
phone call
2
Description
Sepsis
Timepoint
during hospitalization
Method of measurement
Blood cultuer
Intervention groups
1
Description
Less than 4 hours kangaroo mother care
Category
Behavior
2
Description
More than 4 hours kangaroo mother care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Shohre Heidari Farah
Street address
Shahid Fahmide Street
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Heidar tavilani
Street address
Shahid fahmide strit
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shohre Heidari Farah
Position
MD
Other areas of specialty/work
Street address
Hamedan Besat hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0044
Fax
+98 81 1824 9663
Email
sh.heidari@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behnaz Basiri
Position
Neonatology Specialist
Other areas of specialty/work
Street address
Hamedan Fatemieh hospital
City
Hamedan
Postal code
Phone
+98 81 1827 7012
Fax
Email
b.basiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shohre Heidari Farah
Position
MD
Other areas of specialty/work
Street address
Hamedan Besat Hospital
City
Hamedan
Postal code
65178
Phone
+98 81 1264 0033
Fax
Email
sh.heidari@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)