The purpose of this study was to evaluate The effect of Kangroo Mother Care on Primary outcome in Preterm Infants. It is was a single blind study, so that the researchers were not blind but the executive nurse was blind. In this study, 140 infants aged 30-34 weeks with weight>1000g were randomly divided into two groups. The infant in intervention group at least 5 days a week and every half hour during the day and four times receive KMC. The infant in control group within the incubator and the incubator are not removed except for feeding. Finally, outcomes(Blood sugar, weight, height and head circumference) from baseline to discharge will be measured and compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303134617N5
Registration date:2013-03-21, 1392/01/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-21, 1392/01/01
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Kangroo Mother Care on Primary outcome in Preterm Infants:A Controlled randomized clinical trial
Public title
The effect of Kangroo Mother Care on Primary outcome in Preterm Infants:A Controlled randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age infants 34 to 30 weeks of pregnancy; nutrition, exclusive breastfeeding through PO / NGT; no chromosomal abnormalities and congenital anomaly; 5-minute Apgar score of 7; stability physiological birth; weighing more than 1000 grams' mother's mental and physical fitness to participate in the study.
Exclusion criteria: if symptoms such as bradycardia and loss of maternal care during KMC; intervention and were excluded from the study will be stopped; if mothers arms control tend to be taken care of samples will be removed.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Deputy of Research, Tabriz University of Medical Sciences ,Golgasht street , Tabriz,East Azarbaijan
City
Tabriz
Postal code
Approval date
2013-03-09, 1391/12/19
Ethics committee reference number
11453/4/5
Health conditions studied
1
Description of health condition studied
Kangroo Mother Care outcome
ICD-10 code
Z00-Z99
ICD-10 code description
Health supervision and care of other healthy infant and child
Primary outcomes
1
Description
weight gain preterm infant
Timepoint
From baseline to discharge
Method of measurement
Using Seca scale with a precision of 10 g
Secondary outcomes
1
Description
Blood Sugar
Timepoint
From baseline to discharge
Method of measurement
Glocometr ACCU_CHEK Model GC
2
Description
height infant
Timepoint
From baseline to discharge
Method of measurement
centimeter
3
Description
Head circumference infant
Timepoint
From baseline to discharge
Method of measurement
centimeters
Intervention groups
1
Description
The infant in intervention group at least 5 days a week and every half hour during the day and four times receive KMC
Category
Other
2
Description
The infant in control group within the incubator and the incubator are not removed except for feeding
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
29 bahman Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Ostad Rahimi
Street address
Research Department, Central Building , Golgasht , Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Alehe Seyyedrasooly
Position
MSc , Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street , Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
seyyedrasooly@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
MSc, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Shariati South Street , Tabriz , Iran
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
jebreilim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
MSc, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Shariati South Street, Tabriz , Iran
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
East Azarbayjan
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)