| CTRI Number |
CTRI/2015/10/006267 [Registered on: 15/10/2015] Trial Registered Retrospectively |
| Last Modified On: |
11/01/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Formative Research |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Development of Kangaroo Mother Care Package for Low Birth Weight and Preterm Infants in a Community |
Scientific Title of Study
Modification(s)
|
Formative Research to Develop an Intervention Package for Promotion of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community: In Preparation for a Randomized Controlled Trial to Examine Impact of Community Kangaroo Mother Care on Neonatal and Early Infant Mortality |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Sarmila Mazumder |
| Address |
Centre for Health Research and Development, Society for Applied Studies
45, Kalu Sarai, New Delhi-110016, India
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
CHRD@sas.org.in |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Sarmila Mazumder |
| Address |
Centre for Health Research and Development, Society for Applied Studies
45, Kalu Sarai, New Delhi-110016, India
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
CHRD@sas.org.in |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Sarmila Mazumder |
| Address |
Centre for Health Research and Development, Society for Applied Studies
45, Kalu Sarai, New Delhi-110016, India
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
CHRD@sas.org.in |
|
|
Source of Monetary or Material Support
|
| Centre for Intervention Science in Maternal and Child Health (CISMAC), Centre for International Health, University of Bergen, Norway |
|
Primary Sponsor
Modification(s)
|
| Name |
Centre for Health Research and Development Society for Applied Studies |
| Address |
45, Kalu Sarai, New Delhi-110016, India
|
| Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Dr Sunita Taneja |
Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi-110016 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sarmila Mazumder |
Centre for Health Research and Development, Society for Applied Studies |
45, Kalu Sarai
South
|
011-46043751-55
011-46043756
sarmila.mazumder@sas.org.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Review Committee , Centre for Health Research and Development |
Approved |
| Regional Committees for Medical and Health Research Ethics (REC West) in Norway |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Low birth weight and preterm infants |
|
Intervention / Comparator Agent
Modification(s)
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Newborns: Low birth weight or Preterm |
|
| ExclusionCriteria |
| Details |
Babies with hospitalization criteria, unable to feed or weigh <1500 grams at birth |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To determine whether community KMC is feasible to implement in the study setting and if so, can high enough adoption rates be achieved.
To define an intervention package, including the most effective way(s) to promote KMC in the study setting
|
End study |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To ascertain awareness and perceptions around Kangaroo Mother Care |
Throughout the study period |
| To ascertain perceptions, beliefs and practices around pregnancy, delivery and maternal and newborn care |
Throughout the study period |
| To identify social norms around birthing practices for normal, LBW infants and preterms |
Throughout the study period |
| To identify ways to promote Kangaroo Mother Care in the community |
Throughout the study period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="20"
Sample Size from India="20" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
18/04/2015 |
| Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
- |
Brief Summary
Modification(s)
|
The study is being conducted
to develop an intervention to assess the feasibility of implementing KMC for
low birth weight and preterm babies in a community setting. A prototype
intervention package will be developed using information obtained from in-depth
interviews, focus group discussions and other qualitative research techniques.
These interviews will help us identify current behaviours, barriers to adoption
of KMC and effective ways to promote KMC in the community. The prototype
intervention will be refined by conducting acceptability studies (household
trials) with few mothers. The study team are identifying LBW and preterm
infants, demonstrating to mothers how to practice KMC and following up till KMC
is stopped. The process is being documented using observations and interviews.
Information is obtained on acceptability of KMC, number of hours per day and
number of days KMC was given, breastfeeding practices and support provided by other family members. |
