| CTRI Number |
CTRI/2021/09/036103 [Registered on: 01/09/2021] Trial Registered Prospectively |
| Last Modified On: |
23/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to document the long-term benefits of Kangaroo Mother Care (skin to skin contact and exclusive breast feeding) initiated at home during neonatal period on brain development at 6-7 years of child age. |
|
Scientific Title of Study
|
Long term neurodevelopment in low-birth-weight babies who received Kangaroo Mother Care (KMC) compared to those who did not: A follow-up study from community initiated KMC Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Prakash Upadhyay |
| Designation |
Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
ravi.upadhyay@sas.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Prakash Upadhyay |
| Designation |
Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
ravi.upadhyay@sas.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Taneja |
| Designation |
Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sunita.taneja@sas.org.in |
|
|
Source of Monetary or Material Support
|
| DBT Wellcome Trust India Alliance |
|
|
Primary Sponsor
|
| Name |
Centre for Health Research and Development Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, South Delhi-110016, India |
| Type of Sponsor |
Other [Not for profit research organization] |
|
|
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 Ravi Prakash Upadhyay |
Centre for Health Research and Development, Society for Applied Studies |
Centre for Health Research and Development, Society for Applied Studies, Jatola- Asaoti Road, Palwal,
Faridabad, Haryana
Faridabad
HARYANA |
011-46043751-55
ravi.upadhyay@sas.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics review committee, Society for Applied Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children aged 6-7 years born low birth weight |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6-7 years
Children part of the primary trial (CTRI/2016/01/006524)
Children in whom the consent for participation is available from parents/primary caregiver(s)
|
|
| ExclusionCriteria |
| Details |
Those with documented developmental delays e.g. autism, cerebral palsy
Children with documented neuro-psychological problems
For eye tracking assessments, those with documented vision problems e.g. vision impairment, blindness or squint
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Cognitive (IQ) Score
Mean Higher Executive Function Score
|
At child age 6-7 years
At child age 6-7 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean language score
Mean socio-emotional score
Proportion of children with basic reading and arithmetic skills
Eye tracking parameters (Mean saccadic reaction time and mean fixation duration) in a sub-sample of children
|
At child age 6-7 years
At child age 6-7 years
At child age 6-7 years
At child age 6-7 years
|
|
|
Target Sample Size
|
Total Sample Size="2660"
Sample Size from India="2660"
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)
|
10/09/2021 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ravi.upadhyay@sas.org.in].
- For how long will this data be available start date provided 01-12-2026 and end date provided 28-02-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
We did a trial to assess the effect of community-initiated kangaroo mother care (ciKMC) provided to low birth weight (LBW) babies weighing 1500–2250 g on neonatal and infant survival in the first 6 months of life (CTRI/2016/01/006524). Mothers and infants in the intervention group were visited by study team at home (days 1–3, 5, 7, 10, 14, 21, and 28) to support kangaroo mother care (i.e., skin-to-skin contact and exclusive breastfeeding). The control group received routine care. The present study is a follow-up study of LBW infants enrolled in the primary trial. The aim of this follow-up study is to assess the effect of community-initiated Kangaroo Mother Care (ciKMC) compared to routine care during neonatal period on neurodevelopment at 6-7 years of child age. Children enrolled in the main trial will be contacted when they are 6-7 years of age and if consent is available from their parents/caregiver(s), neurodevelopment assessments will be conducted by the trained psychologists. The assessments among the enrolled children will be done by using the following tools: Wechsler Intelligence scale for children (WISC-IVINDIA), neuropsychological test battery (NEPSY-II), Behavior rating inventory of executive function (BRIEF-2), and Annual status of education report (ASER). Eye tracking assessments will be conducted in a sub-sample of children. The duration of this study is 5 years. In the first year, study preparatory activities such as obtaining ethical clearance, procurement of psychometric assessment tools, setting up of assessment clinic and recruitment and training of the team was undertaken. Enrolment of the first child will be done after the CTRI registration. |