| CTRI Number |
CTRI/2017/04/008430 [Registered on: 27/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Biology underlying Kangaroo Mother Care] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Infections and growth in low birth weight infants: Role of community initiated kangaroo mother care on breast milk and underlying biological pathways |
Scientific Title of Study
Modification(s)
|
Effect of community initiated kangaroo mother care in low birth weight infants on linear growth, infection reduction, breast milk properties and related biological outcomes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bireshwar Sinha |
| Designation |
Research Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Society for Applied Studies,
45, Kalu Sarai
New Delhi
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
|
| Email |
bireshwar.sinha@sas.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bireshwar Sinha |
| Designation |
Research Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Society for Applied Studies,
45, Kalu Sarai
New Delhi
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
|
| Email |
bireshwar.sinha@sas.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarmila Mazumder |
| Designation |
Senior Scientist and Deputy Director |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Society for Applied Studies,
45, Kalu Sarai
New Delhi
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
|
| Email |
sarmila.mazumder@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
|
| Name |
Centre for Health Research and Development Society for Applied Studies |
| Address |
45, Kalu Sarai, New Delhi -110016 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bireshwar Sinha |
Centre for Health Research and Development, Society for Applied Studies |
Village Jatola, District Palwal, Tatarpur
Faridabad
HARYANA |
011-46043751-55
CHRD@sas.org.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Review Committee, Centre for Health Research and Develoment Society for Applied Studies |
Approved |
| Ethics Review Committee, Centre for Health Research and Develoment Society for Applied Studies |
Approved |
| Ethics Review Committee, Centre for Health Research and Develoment Society for Applied Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Low Birth Weight Mother Infant Dyads |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KMC |
Promotion of and support to provide early skin to skin care as soon as possible after birth initiated at the community. Support for breastfeeding to promote optimal breastfeeding practice. Neonatal and post-neonatal care as per national guidelines. |
| Comparator Agent |
No intervention |
Neonatal and post neonatal care as per national guidelines |
|
|
Inclusion Criteria
|
| Age From |
4.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Singleton Low birth weight babies (≥1500 to ≤2250 g) included in the trial titled “Effect of Community Initiated Kangaroo mother care on babies with Low Birth Weight†who are either born at home or hospital but KMC not initiated in the hospital. |
|
| ExclusionCriteria |
| Details |
1.Infant unable to feed
2.Infant has breathing problem or is less active
3.Twins or triplets
4.Gross congenital malformations
5.Mother does not intend to stay in the study area for the next 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. LAZ score (4600 sample size)
2. Postpartum depressive symptoms (1950 sample size) |
End of neonatal period
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Breast milk antimicrobial proteins(in a sub sample) |
3rd week of life |
| Breastfeeding performance: successful breastfeeding, lactation failure and use of breast milk substitutes (in a sub sample) |
at the end of neonatal period |
| Maternal stress and cortisol levels(sub sample of 550) |
at the end of neonatal period |
| Gut inflammatory markers: Fecal Calprotectin, Myeloperoxidase, alpha1antitrypsin(in a sub sample) |
at the end of neonatal period |
| Relative abundance of and diversity of infant gut microbiome (in a sub sample) |
at the end of neonatal period |
| Infant breast milk intake during the neonatal period (sub sample of 550 infants) |
neonatal period |
| LAZ and WHZ score |
3 and 6 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="4600"
Sample Size from India="4600"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Kangaroo Mother Care (KMC) is a unique intervention shown to promote survival in low birth weight infants in health facilities, but the underlying pathways are unclear. To study impact of community initiated KMC, investigators from Society for Applied Studies are conducting a trial on the same with the primary outcome as neonatal mortality titled “Effect of Community Initiated Kangaroo mother care on babies with Low Birth Weightâ€. This trial provides an opportunity to add mechanistic outcomes to explain underlying pathways. We propose to embed within the large intervention trial, a sub-study, which will assess impact of KMC in LBW infants on linear growth, possible serious bacterial infection, infant breast milk intake and breast milk quality, maternal stress reduction, infant skin maturity and gut microbiome. Linking this mechanistic sub-study to explain pathways is an innovative way to add value to the public health trial to fill some critical knowledge gaps and provide evidence whether KMC can promote linear growth and reduce infections which are key to survival of LBW babies. |