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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  
Status 
Not Applicable 
 
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.


 
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