Low-Birth-Weight Clinical Trial
Official title:
Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants
This study is being conducted to assess the impact of promoting community initiated Kangaroo
Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and
mortality post enrolment upto 6 months of age. This large individually randomized controlled
trial will enroll 10500 low birth weight babies. The secondary objectives are examining the
impact of the intervention on exclusive breast feeding and growth at 1 and 3 months,
infections and hospitalizations in the neonatal period and from 1 to 5 months of age,
recognition of illnesses and early care seeking from appropriate sources, motor and mental
development in a subsample.
Newborns weighing >=1500 to <=2250gm are being enrolled into the study within 3 days of
birth. Eligible babies are randomized to intervention or control arms. Mothers in the
intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse
Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home
visits are conducted in both intervention and control arms by government workers according to
the existing government program.
Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.
The data safety and monitoring committee (DSMC) conducted two interim analyses, first in
September 2017 when about half of the infants had been enrolled, and second in June 2018,
when almost three quarters of the enrolled babies had been followed till 28 days of age.
Following the second interim analysis, the DSMC concluded that a sufficient number of infants
would be enrolled by the end to September 2018 to clearly answer the study question
concerning the impact of ciKMC on both neonatal and early infant mortality. The DSMC
recommended that data collection be completed by the end of October 2018.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02613624 -
Formative Research to Develop an Intervention Package to Promote Practice of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community (CKMC)
|
N/A |