Immediate KMC Study
The study aims to evaluate the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to <1.8 kg on their survival in low-resource settings . This multi-country randomized clinical study has been implemented in tertiary care hospitals in five low- and middle-income countries in Asia and Sub-Saharan Africa (India, Ghana, Malawi, Nigeria and Tanzania). In this study, the proposed method of care will be provided to infants with a birth weight between 1.0 to <1.8 kg. This will be compared with the current recommended method of initiating continuous KMC after stabilization of the neonate. All neonates enrolled in this study will receive the WHO minimum package of care for small babies (warmth, hygiene, breast-milk feeding, and if required intravenous fluids, parenteral antibiotics, oxygen, continuous positive airway pressure, and monitoring). This care will be the same for the intervention and control groups, except that babies randomized to intervention will be given continuous KMC with mothers or surrogates in the neonatal special care unit, but babies allocated to control group will receive care in incubators, radiant warmers or cots while they are unstable.
CDSA is collaborating with VMMC and SJH for conduct of the study at the India site (Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi) and is responsible for the finance management, Internal Quality Improvement and data management support to the site in India. Duration of this collaboration will be of 3 years (up to 2020).
|Project Title:||A multi-country randomized clinical trial to evaluate the impact of continuous KMC initiated immediately after birth compared to KMC initiated after stabilization in new-borns with birth weight 1.0 to <1.8 kg on their survival in low-resource settings (iKMC Study)|
|In India, study initiated in November 2017 and so far we have recruited more than 200 babies in both intervention and control groups.|
|Study Sites:||1. GSVM,Kanpur
2. KGMU, Lucknow
3. AMCH, Dibrugarh
4. SRM, Chennai
5. JSS, Mysore
| Completed subject enrolment.
• QC and data freezing of 410 subjects completed.
• 1st DSMB meeting completed
- Dr. Nitya Wadhwa
- Mr. Ashish Dass