Protocol summary

Summary
The goal of our study was to assess the effect of kangaroo mother careon the weightgain of low birth weight neonates. Inclusion criteria included infants who weighed 2500 g and exclusion criteria included tobe worse infants, connection to the ventilator, lack of breast feeding and mother,s non-cooperation. 50 neonates with the history of low birth weight will assess. The patients will devide into two groups. The intervention group consist of 25 kangaroo mother careinfants and the control group contain 25 non KMC or routine conventional care infans.in both groups breast-fed infants and appear to embrace maternal ban (intubation, etc.) . Intervention group is set Skin contact between mother and baby a time of day.The control group are receive routine care and feeding. Every day each group weight in one hour with a scale and in a dry diaper and clothes until discharge and the numbers are recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201209094431N2
Registration date: 2013-07-20, 1392/04/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-20, 1392/04/29
Registrant information
Name
Mahdi Rezvani Amin
Name of organization / entity
Baghiatallah University
Country
Iran (Islamic Republic of)
Phone
+98 54 1241 9085
Email address
rezvaniamin@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Personal
Expected recruitment start date
2012-10-21, 1391/07/30
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
The effect of kangaroo mother care in weight gain of low birth weight neonates at 17 Shahrivar and 22 Bahman hospitals
Public title
The effect of kangaroo mother care in weight gain of low birth weight neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included infants who weighed 2500 g and exclusion criteria included tobe worse infants, connection to the ventilator, Lack of breast feeding and mother,s non-cooperation
Age
From 10 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Faculty of Medicine, Islamic Azad University of Mashhad
Street address
Khosravi across four lanes Registration - Medical Shahinshahr
City
Mashhad
Postal code
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
132456

Health conditions studied

1

Description of health condition studied
LBW
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight

Primary outcomes

1

Description
Weight
Timepoint
Every day
Method of measurement
With Scale

Secondary outcomes

empty

Intervention groups

1

Description
Skin contact between mother and baby at a time of day is set. Every day, infants will weight without clothes and with a dry diaper an hour by a person and the numbers are recorded.
Category
Behavior

2

Description
The control group are receive routine care and feeding schedule. Every day, infants will weight without clothes and with a dry diaper an hour by a person and the numbers are recorded
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Street address
City
Mashhad

2

Recruitment center
Name of recruitment center
17 shahrivar hospital
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Azad University of Mashhad
Full name of responsible person
Dr Saeid Abtahi
Street address
Mashhad Azad University - School of Medicine
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University of Mashhad
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
Zahedan University of Medical Sciences
Full name of responsible person
Fatihe kerman Saravi
Position
MSc
Other areas of specialty/work
Street address
Midwifery School, Meidan Mashahir, Zahedan,
City
Zahedan
Postal code
Phone
+98 54 1241 1515
Fax
Email
Fkermansaravi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad Azad University - School of Medicine
Full name of responsible person
Mahdiye Jafari
Position
MD
Other areas of specialty/work
Street address
Mashhad Azad University - School of Medicine
City
Mashhad
Postal code
Phone
+98 51 1879 6099
Fax
Email
mahdiye_jafari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatihe Kerman Saravi
Position
MSc
Other areas of specialty/work
Street address
Nursing & Midwifery School, Meidan Mashahir, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1241 1415
Fax
Email
Fkermansaravi@yahoo.com
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
Loading...