| CTRI Number |
CTRI/2024/04/065235 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Modify and strengthen existing MCH Programs] |
| Study Design |
Other |
|
Public Title of Study
|
Sankalp: Mission Single Digit Neonatal Mortality |
|
Scientific Title of Study
|
Sankalp: Strengthening Program Implementation and Monitoring to
Achieve Single-digit Neonatal Mortality |
| Trial Acronym |
SANKALP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amlin Shukla (Study Coordinator) |
| Designation |
Scientist D |
| Affiliation |
Indian Council of Medical Resarch |
| Address |
V Ramalingaswami Bhawan ICMR Headqauters Ansari Nagar
New Delhi DELHI 110029 India |
| Phone |
8447125128 |
| Fax |
|
| Email |
dr.amlinshukla@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amlin Shukla |
| Designation |
Scientist D |
| Affiliation |
Indian Council of Medical Resarch |
| Address |
V Ramalingaswami Bhawan ICMR Headqauters Ansari Nagar
New Delhi DELHI 110029 India |
| Phone |
8447125128 |
| Fax |
|
| Email |
dr.amlinshukla@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Amlin Shukla |
| Designation |
Scientist D |
| Affiliation |
Indian Council of Medical Resarch |
| Address |
V Ramalingaswami Bhawan ICMR Headqauters Ansari Nagar
New Delhi DELHI 110029 India |
| Phone |
8447125128 |
| Fax |
|
| Email |
dr.amlinshukla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bill & Melinda Gates Foundation.
Capital Court, The, 5th Floor, Olof Palme Marg, Munirka, New Delhi, Delhi 110067 |
| Indian Council of Medical Research, Headquarters
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V Ramalingaswami Bhawan ICMR Headquaters Ansari Nagar New Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bill and Melinda Gates Foundation |
Capital Court 5th floor Olof Palme Marg Munirka New Delhi 110067 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajeev Bijalwan |
District hospital, Sub-district hospital, Primary Health Centres & Sub-centres of Haridwar |
PIs Address: Rural Development Institute, Swami Rama Himalayan University, Swami Ram Nagar, Jolly Grant, Dehradun-248016. (The study will be conducted in the Haridwar district) Hardwar UTTARANCHAL |
9410153938
rbijalwan@hihtindia.org |
| Prof Sutapa B Neogi |
District Hospital, Sub-district hospital, Primary Health Centres, Sub-Centre of Unnao |
PIs Address: International Institute of Health Management Research (IIHMR), Delhi. (The study will be conducted in the Unnao district) Unnao UTTAR PRADESH |
991002889
sutapa@iihmrdelhi.edu.in |
| Dr Praveen Kumar |
Medical college, District hospital, Primary Health Centres, Sub-Centre of Ambala |
PIs Address: Division of Neonatology, Department of Pediatrics, Post Graduate Institute of
Medical Education and Research (PGIMER), Sec-12, Chandigarh,Pincode-160012, Chandigarh
(The study will be conducted in the Ambala district) Ambala HARYANA |
9478366925
drpkumarpgi@gmail.com |
| Dr Prem K Mony |
Medical college, District hospital, Primary Health Centres, Sub-Centre of Koppal |
PIs Address: St. Johns Research Institute, St. Johns National Academy of Health Science, Bangalore. (The study will be conducted in the Koppal district) Koppal KARNATAKA |
9535007638
prem_mony@sjri.res.in |
| Dr Harish Chellani |
Medical College, District hospital, Sub-district hospital, Primary Health Centres of Dungarpur |
PIs Address: Society for Applied Studies, 45, Kalu Sarai, New Delhi-110016. (The study will be conducted in the Dungarpur district) Dungarpur RAJASTHAN |
9810313072
harish.chellani@sas.org.in |
| Dr S Thanigainathan |
Medical College, Private Hospital, Primary Health Centres & Sub-centres of Adilabad |
PIs Address: AIIMS Bibinagar, Hyderabad Metropolitan city, Telangana, 508126 (The study will be conducted in the Adilabad district) Adilabad TELANGANA |
9176078520
thanigaipaeds@gmail.com |
| Dr Arup Chakraborty |
Medical College, Private Hospital, Primary Health Centres & Sub-centres of Murshidabad |
PIs Address: Department of Community Medicine, Medical College, MCH Building, fourth
Floor, 88, College Street, Kolkata 700073. (The study will be conducted in the Murshidabad district) Murshidabad WEST BENGAL |
9830885650
dr.arupchakraborty@gmail.com |
| Dr Ramesh Agarwal |
Medical college, Sub-district hospital, Primary Health Centre, Sub-Centre of Khargone |
PIs Address: All India Institute of Medical Sciences, New-Delhi (The study will be conducted in the district Khargone) West Nimar MADHYA PRADESH |
9810756718
ra.aiims@gmail.com |
| Dr Vishwajeet Kumar |
Medical college, Sub-district hospital, Primary Health Centres, Sub-Centre of Varanasi |
PIs Address: Community Empowerment Lab; A-6/14, Vineet Khand, Gomti Nagar, Lucknow, Uttar
Pradesh – 226010
(The study will be conducted in the Varanasi city).
Varanasi UTTAR PRADESH |
7217863617
vkumar@celworld.org |
| Dr Manoja Kumar Das |
Sub-district Hospitals, Primary Health Centre & Sub-centres of Purnia |
PIs Address: The INCLEN Trust International, F1/5, Okhla Industrial Area, Phase I, New Delhi-110020. (The study will be conducted in the Purnia district) Purnia BIHAR |
9810203768
manoj@inclentrust.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Review Committee Centre for Health Research and Development Society for Applied Studies |
Submittted/Under Review |
| INCLEN Independent Ethics Committee |
Submittted/Under Review |
| Institute Ethics Committee, All India Institute of Medical Sciences, Ansari Nagar, New Delhi |
Submittted/Under Review |
| Institutional Ethics Committee (AIIMS BBN-IEC) |
Submittted/Under Review |
| Institutional Ethics Committee, Community Empowerment Lab |
Submittted/Under Review |
| Institutional Ethics Committee, Medical College. Kolkata |
Submittted/Under Review |
| Institutional Ethics Committee, St. Johns Medical College & Hospital |
Submittted/Under Review |
| International Institute of Health Management Research, Institutional Review Board |
Submittted/Under Review |
| Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics committee |
Submittted/Under Review |
| Swami Rama Himalayan University, Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Conditions for pregnant women: O00-O08, O09-O09, O10-O16, O20-O29, O30-O48, O60-O77, O80-O82.
Conditions for neonates: P01, P02, P07, P10-P15, P20-P21, P22, P23-P28, P35-P39, P50-P52, P29, P70-P83, R95 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modify and strengthen existing MCH Programs |
The care components at the health facility and community levels are grouped under five packages:
1. Package 1: Care during labour and childbirth
2. Package 2: Care of small and sick newborn
3. Package 3: Care of healthy newborn
4. Package 4: Immediate newborn care at delivery
5. Package 5: Antenatal care and pre-conception care
The intervention will be carried out in phases starting from formative research to understand the barriers to effective implimentations of goverment program followed by a codevelopment phase where solutions will be codeveloped in consultation with the local stakeholders. In the next phase the identified implimentation strategies will be employed to bring about a better implementation of above care packages.
The total duration of study will be 3.5 years out of which implementation phase will be of 18 months.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates |
|
| ExclusionCriteria |
| Details |
Refusal for consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neonatal mortality rate
|
Outcome will be studied at various time points in the form of an interrupted time series. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Perinatal mortality rate
2. Proportion of newborns who were provided early (within one hour) & exclusive breastfeeding
3. Proportion of low-birth-weight newborns who were initiated & sustained on KMC as per WHO
guidelines
4. Proportion of mother-newborn dyads who stayed for at least 24 hours post birth in a delivery facility & received the complete facility-based care package.
5. Implimentation outcome.
6. Process & coverage outcome.
|
42 months |
|
|
Target Sample Size
|
Total Sample Size="96000" Sample Size from India="96000"
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)
|
25/04/2024 |
| 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="3" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background & rationale: While India has made significant strides in reducing child mortality, nearly 5 lakh newborns continue to die each year, mostly due to preventable causes. Further, newborn survival is a field with a well-established evidence base of impactful interventions that have also been integrated into the national policy, but with persistent challenges in last-mile delivery. This “know-do†gap between evidence-based practices and how to implement them to achieve high coverage and quality at scale can be bridged through implementation research (IR) in close partnership with the health system. There are wide inter-state, inter-district, and potentially even intra-district variations in the neonatal mortality rate (NMR). Prematurity, birth asphyxia and infections are the main causes of neonatal deaths, but their relative distribution may vary with the NMR and local context across regions. Therefore, this multi-state multi-district IR study has been designed to develop effective implementation strategies for a package of evidence-based interventions that are contextualized to different state/regional contexts with the goal of achieving single-digit NMR in each study district. Research question: How to achieve a single-digit neonatal mortality rate (NMR) in selected high-NMR districts of India by developing and optimizing an implementation model for delivering evidence-based practices to pregnant women and newborns? Objectives: 1. To co-develop and optimize context-specific/ contextualized implementation strategies for achieving high and equitable coverage and quality of evidence-based practices (EBP) for reducing neonatal mortality. 2. To document the process of evolution (adaptation and fidelity) of the implementation model. 3. To evaluate the effect of the optimized and contextualized implementation model on the neonatal mortality rate.
|