Comparison of Kangaroo mother care and conventional method in premature of less than 2000 grams birth weight in weight gaining, clinical cyanosis, mother confidence, hospitalization and nosocomial infections
Objective: The aim of study was to compare the effect of Kangaroo mother care (KMC) and conventional methods of care (CMC) in premature low birth weight babies less than 2000 grams birth weight in weight gaining, clinical cyanosis, mother confidence, hospitalization and nosocomial infections. Method: One hundred babies with birth weight less than 2000 grams and without clinical problem will randomly divided in two groups, the intervention group (N=50) receive Kangaroo mother care and the control group (N=50) receive conventional care. Two groups will compare in daily weight gaining, self confidence of mother, duration of hospitalization, clinical cyanosis and nosocomial infections.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101091162N16
Registration date:2011-02-10, 1389/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-10, 1389/11/21
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2007-03-07, 1385/12/16
Expected recruitment end date
2009-01-31, 1387/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Kangaroo mother care and conventional method in premature of less than 2000 grams birth weight in weight gaining, clinical cyanosis, mother confidence, hospitalization and nosocomial infections
Public title
Comparison of Kangaroo mother care and conventional method in premature of less 2000 grams birth weight in weight gaining, clinical cyanosis, mother confidence, hospitalization and nosocomial infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Babies with birth weight less than 2000 gr which were stabilized in first 72 hr of age Exclusion criteria: babies with requiring ventilator support, suffering from apnea, unstable temperature, and intravenous nutrient
Age
From 2 years old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Mashhad University of medical sciences
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
13131-91379
Approval date
2006-12-26, 1385/10/05
Ethics committee reference number
11471/51
Health conditions studied
1
Description of health condition studied
nosocomial infection
ICD-10 code
Y95
ICD-10 code description
Nosocomial condition
2
Description of health condition studied
duration of hospitalization
ICD-10 code
Z59.3
ICD-10 code description
Problems related to living in residential institution
3
Description of health condition studied
weight gaining
ICD-10 code
R62.8
ICD-10 code description
Other lack of expected normal physiological development
4
Description of health condition studied
self confidence of mother
ICD-10 code
F69
ICD-10 code description
Unspecified disorder of adult personality and behaviour
5
Description of health condition studied
cyanosis
ICD-10 code
R23.0
ICD-10 code description
Cyanosis
Primary outcomes
1
Description
weight gaining
Timepoint
daily
Method of measurement
with scale
2
Description
mother confidence
Timepoint
daily
Method of measurement
clinical
3
Description
hospitalization
Timepoint
daily
Method of measurement
at discharge
4
Description
cyanosis
Timepoint
daily
Method of measurement
clinical
5
Description
nosocomial infections
Timepoint
daily
Method of measurement
positive culture of blood, CSF, Urine
Secondary outcomes
1
Description
temperature instability
Timepoint
q 6 hours
Method of measurement
with termometer
Intervention groups
1
Description
kangaroo mother care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
neonatal research center of Mashhad university of medical sciences
Full name of responsible person
Dr.Ashraf Mohammadzadeh
Street address
Neonatal research center- NICU- Emamreza hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Dr Jalil Tavakol Afshari
Street address
Ghoreshi bulding, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Neonatal Research Center
Full name of responsible person
Dr. Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Sharing plan
Deidentified Individual Participant Data Set (IPD)