| CTRI Number |
CTRI/2023/03/050420 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| 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 = 1 |
| 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 |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Review Committee, Centre for Health Research and Development, 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
|
| Outcome |
TimePoints |
| Proportion of preterm or LBW infants who died during the first 28 days of life (among the trial participants). The primary outcome will be analysed globally in the 24 clusters |
29th day of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Breastfeeding:
1. Proportion of preterm or LBW infants who are exclusively breastfed at discharge from trial facilities
2. Median age at putting the baby to the breast for the first-time during M-SNCU/SNCU stay
3. Median age at initiation of breastmilk feeding during the M-SNCU/SNCU stay
|
From day of birth till time of discharge |
| Proportion of preterm or LBW infants with clinical sepsis: As diagnosed by the attending physician either defined by clinical signs alone or presence of clinical signs with positive laboratory screening test while in M-SNCU/SNCU |
From day of birth till time of discharge |
| Proportion of preterm or LBW infants who has hypoglycaemia: Any blood glucose level of less than 45 mg per deciliter, measured when clinically indicated during M-SNCU/SNCU stay, as per the SNCU protocol of each study |
From day of birth till time of discharge |
| Proportion of preterm or LBW infants who has hypothermia: Any axillary temperature less than 36°C during M-SNCU/SNCU stay |
From day of birth till time of discharge |
| Proportion of preterm or LBW infants receiving KMC at discharge (8-24 hours of skin-to-skin contact in the 24 hours and exclusively breastfed) before discharge from the trial facility |
From day of birth till time of discharge |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/05/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Annually 20 million are born with low birth weight
(LBW) as a result of
being delivered as small for gestational age or preterm About 32 million are born small for
gestational age and 15 million are born preterm. These newborns
are vulnerable to an increased risk of death and development challenges. These
vulnerable newborns not only account for 80% of all neonatal deaths but also
are at increased risk of short- and long-term respiratory, infectious,
metabolic and neurological morbidities, with higher risks of adverse outcomes
seen at lower gestational ages.
KMC is defined as early, prolonged, and continuous
skin-to-skin contact between mother and her preterm or LBW newborn, and
exclusive breastfeeding or breastmilk feeding. In 2016 a Cochrane review
reported on 21 randomized controlled trials (3042 infants) that compared KMC with
conventional neonatal care in health facilities and showed that KMC reduced
mortality by 40% (RR 0.60, 95% CI 0.39 to 0.92), nosocomial infections by 65%
(RR 0.45, 95% CI 0.27 to 0.76) and hypothermia by 64% (RR 0.34, 95% CI 0.17 to
0.67). It was also reported that KMC increased weight, length, and head
circumference, breastfeeding, mother satisfaction with the method of infant
care and maternal-infant attachment, and improved child development
KMC initiated immediately after birth for 1.0 to
<1.8 kg infants significantly reduced the risk of neonatal death by 25%.
Scale-up KMC study showed that with a committed workforce, respectful maternity
care and government leadership, KMC coverage could increase to 80%. The
evidence of the efficacy of iKMC is clear. IKMC reduces mortality in LBW babies
by 25%. The number needed
to treat is 27, which means that the intervention provided to 27 LBW babies
will save one life. Globally, there are about 4 million babies (of the 20
million LBW babies) that would be eligible for this intervention. If all these
babies received iKMC, about 150,000 lives would be saved every year. The key
issue is to achieve high-quality, universal coverage of iKMC in the target
population.
WHO recommendations for the care of the preterm and
LBW baby have recently been updated, and this update takes into
consideration all the new evidence on the trilogy of KMC, including that on
scale-up of facility-KMC, community-initiated KMC, and iKMC as mentioned above.
The India newborn action plan (INAP) recommended
establishment of fully functional KMC wards in health facilities. The Ministry of Health and Family Welfare
(MoHFW) allotted funds to states to create KMC spaces within the special
newborn care units (SNCUs), with 90% KMC coverage targets by 2030 (MoHFW,
2014).
Haryana government has always been in the
forefront, proactively taking actions to improve of maternal, newborn and child
health in the state. The department of Health in Haryana has developed a
model for comprehensive care of small and sick neonates which is currently
implemented in 9 districts, and the government is in agreement to partner with
the local research organization, Centre of Health Research and Development,
Society for Applied Studies (CHRD SAS), to build an effective and efficient
model for care of small sick newborns through the proposed
implementation research. A consortium has been formed by CHRD SAS, the
team from Safdarjung hospital, that pioneered the M-NICU in Delhi for the
immediate KMC randomized controlled trial, and the Translational Health Science
and Technology Institute (THSTI) to scale up the immediate KMC in selected
districts in Haryana. The Government program managers and researchers will
jointly make up the study team. Safdarjung Hospital (SJH), the only site in
Asia that contributed to 43% sample size for the multi-center study on
immediate KMC. The Mother-Newborn Care Unit (MNICU) was designed by the
SJH-THSTI technical team. The SJH-THSTI team will be responsible for developing
the intervention and implementation strategy for the district hospitals. SJH
will serve as a demonstration site and training center, with on-site training
support for the district pool of trainers and government personnel responsible
for program implementation. They will also conduct periodic meetings with the
government personnel to review the progress and work together to resolve
barriers. |