| CTRI Number |
CTRI/2023/03/050420 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Implementing Kangaroo Mother Care soon after birth in district hospitals |
|
Scientific Title of Study
|
Implementation Research to Scale-up and Evaluate the Impact of Immediate Kangaroo Mother (iKMC) Care on Newborn Outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
45 Kalu Sarai, New Delhi
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
45 Kalu Sarai, New Delhi
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
45 Kalu Sarai, New Delhi
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
|
Source of Monetary or Material Support
|
| World Health Organization (WHO), Geneva, Switzerland |
|
|
Primary Sponsor
|
| Name |
Centre for Health Research and Development Society for Applied Studies |
| Address |
45, Kalu Sarai, New Delhi |
| Type of Sponsor |
Other [Research Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarmila Mazumder |
Civil Hospital Ambala City |
Civil Hospital Ambala City
Model Town Road, Polytechnic Chowk, Ambala, Haryana 134003
Ambala
HARYANA |
011-46043751-55
011-46043756
sarmila.mazumder@sas.org.in |
| Dr Sarmila Mazumder |
Civil Hospital, Kurukshetra. |
Civil Surgeon Office, Kurukshetra
Location LNJP Hospital, Near Kurukshetra University
Kurukshetra
HARYANA |
46043751-55
011-46043756
sarmila.mazumder@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 Development, Society for Applied Studies |
Approved |
| Ethics Review Committee, Society for Applied Studies |
Approved |
| Haryana State Government approval |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preterm / Low birth weight newborn babies |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional care |
Essential package of care for small and sick newborns, including KMC |
| Intervention |
Immediate Kangaroo Mother Care (iKMC) |
• Skin-to-skin contact is initiated within 2 hours after birth if the baby is born within the iKMC implementing facility; if the baby is born outside, then within 2 hours of reaching the iKMC implementing facility (for those babies who reach the facility within 24 hours of birth)
• Continuous skin-to-skin contact is provided by a mother/surrogate for at least 8 hours per day during the stay in the level 2 M-SNCU (average hours per day for the overall M-SNCU stay)
• Support for early and exclusive breastmilk feeding is provided to the mother
• Required medical care for the mother and baby is provided without separation, as much as possible
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Preterm or LBW newborns (gestational age <37 weeks or birthweight<2.5 kg) requiring care in the SNCU, i.e., who are below the country cut-off point for birthweight or gestational age for SNCU admission, or those preterm or LBW newborns who are above the cut-off but are sick and need SNCU admission. |
|
| ExclusionCriteria |
| Details |
Preterm or LBW newborns requiring SNCU care who are critically sick, for example: are unable to breathe spontaneously within the first hour after birth or have congenital malformations that interfere with the intervention, or the intervention interferes with the required care for the congenital malformation (e.g., anencephaly, congenital heart disease, gastroschisis, hydrocephaly, multiple malformations, omphalocele, tracheoesophageal fistula, abdominal detention. etc.) are in shock (in need of inotropes) in the first 2 hours of birth or
are receiving mechanical ventilation (invasive mechanical ventilation) in the first 2 hours of birth; or Liveborn who died in the first 2 hours of birth or first 2 hours of admission or were dead at the time of admission to the iKMC implementing facility
These neonates (except deceased newborns) will be excluded from the study for outcome measurement purposes however they all newborns will receive appropriate care in the iKMC implementing facility.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. iKMC coverage for inborn babies: proportion of preterm or LBW newborns born in the iKMC implementing facility, who received iKMC.
2. iKMC coverage for outborn babies: proportion of preterm or LBW newborns brought to the iKMC implementing facility within 24 hours of birth, who received iKMC. |
29th day of life |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1. Respiratory support & skin-to-skin contact: proportion of preterm & or LBW infants on respiratory support (any oxygen or CPAP) in the newborn care unit or MNCU who received skin-to-skin contact greater than equal to 8 hours per day |
From day of birth till time of discharge |
| 2. Early breastfeeding initiation: median age at putting the baby to breast for the first time (Expressed in median hours per days) |
From day of birth till time of discharge |
| 3. Early breast milk feeding initiation: median age of first feeding with human milk (Expressed in median hours per days) |
From day of birth till time of discharge |
| 4. Effective KMC at discharge: proportion of preterm & or LBW infants receiving KMC (skin-to-skin care greater than equal to 8 hours & exclusively breast milk fed) at discharge from the iKMC implementing facility |
From day of birth till time of discharge |
|
Target Sample Size
Modification(s)
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
16/01/2026 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
iKMC-IR Study Group, Yoshida S and Portela A. Integrating immediate Kangaroo Mother Care as an integral part of small and sick newborn care in facilities with level 2 Special Newborn Care Units: Implementation Research Protocol [version 2; peer review: 1 approved]. VeriXiv 2026, 2:148 (https://doi.org/10.12688/verixiv.1215.2) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The implementation research project focuses on programmatic strengthening through a 10-month phased scale-up in a single district in Haryana. Eschewing a randomized trial design, the study utilizes a government-led prioritization process to select sites based on immediate scale-up needs and health system readiness. The methodology centers on a strategic, phased roll-out where the intervention is introduced only when facilities demonstrate the necessary infrastructure and capacity. This approach ensures that the research remains deeply embedded within the existing maternal and newborn health services, prioritizing sustainable growth and real-world application over experimental variables. |