Clinical Trial: Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants

Brief Summary:

This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (KMC) 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.


Detailed Summary:
Sponsor: Society for Applied Studies

Current Primary Outcome:

  • Neonatal mortality from post enrolment to 28 days [ Time Frame: From post enrolment to 28 days ]
  • Early infant mortality from post enrolment to 6 months of age [ Time Frame: From post enrolment to 6 months ]


Original Primary Outcome:

  • Neonatal mortality [ Time Frame: From birth to 28 days ]
  • Early infant mortality from birth to 6 months [ Time Frame: From birth to 6 months ]


Current Secondary Outcome:

  • Proportion exclusively breastfed at 1 and 3 months [ Time Frame: 1 month, 3 months ]
  • Weight gain [ Time Frame: 1, 3 and 6 months ]
  • Length gain [ Time Frame: 1, 3 and 6 months ]
  • Incidence of infection and hospitalization [ Time Frame: 1 month and 1 to 5 months ]
  • Early recognition of illness at 1 month [ Time Frame: 1 month period ]
    Recognition of illness will be ascertained from caregivers by using questionnaire
  • Early appropriate care seeking practices at 1 month [ Time Frame: 1 month period ]
    Early appropriate care seeking ascertained from caregivers by using questionnaire
  • Early recognition of illness at 3 months [ Time Frame: Assessed at 3 months, data from 1 month upto 3 months ]
    Recognition of illness ascertained from caregivers by using questionnaire
  • Early appropriate care seeking practices at 3 months [ Time Frame: Assessed at 3 months, data from 1 month upto 3 months ]
    Early appropriate care-seeking ascertained from caregivers by using questionnaire
  • Early recognition of illness at 6 months [ Time Frame: Assessed at 6 months, data from 3 months upto 6 months ]
    Recognition of illness ascertained from caregivers by using questionnaire
  • Early appropriate care seeking practices at 6 months [ Time Frame: Assessed at 6 months, data from 3 months upto 6 months ]
    Early appropriate care-seeking practices ascertained by using questionnaire
  • Assessment of cognitive function by Bayley scale in a subsample [ Time Frame: Assessment of cognitive function by Bayley scale at 6 months ]
  • Assessment of cognitive function by Bayley scale in a subsample [ Time Frame: Assessment of cognitive function by Bayley scale at 12 months ]
  • Head circumference [ Time Frame: 1, 3 and 6 months ]


Original Secondary Outcome:

  • Early initiation of breastfeeding [ Time Frame: 1 month ]
  • Proportion exclusively breastfed at 1 and 3 months [ Time Frame: 1 month, 3 months ]
  • Weight gain [ Time Frame: 1, 3 and 6 months ]
  • Length gain [ Time Frame: 1, 3 and 6 months ]
  • Incidence of infection in neonates at 1 month [ Time Frame: 1 month ]
  • Early recognition of illness at 1 month [ Time Frame: 1 month period ]
    Recognition of illness will be ascertained from caregivers by using questionnaire
  • Early appropriate care seeking practices at 1 month [ Time Frame: 1 month period ]
    Early appropriate care seeking ascertained from caregivers by using questionnaire
  • Early recognition of illness at 3 months [ Time Frame: Assessed at 3 months, data from 1 month upto 3 months ]
    Recognition of illness ascertained from caregivers by using questionnaire
  • Early appropriate care seeking practices at 3 months [ Time Frame: Assessed at 3 months, data from 1 month upto 3 months ]
    Early appropriate care-seeking ascertained from caregivers by using questionnaire
  • Early recognition of illness at 6 months [ Time Frame: Assessed at 6 months, data from 3 months upto 6 months ]
    Recognition of illness ascertained from caregivers by using questionnaire
  • Early appropriate care seeking practices at 6 months [ Time Frame: Assessed at 6 months, data from 3 months upto 6 months ]
    Early appropriate care-seeking practices ascertained by using questionnaire
  • Assessment of cognitive function by Bayley scale [ Time Frame: Assessment of coginitve funcion by Bayley scale at 6 months ]
  • Assessment of cognitive function by Bayley scale [ Time Frame: Assessment of coginitve funcion by Bayley scale at 12 months ]
  • Assessment of equity across varies wealth quintiles [ Time Frame: 6 months ]
    Equity of intervention will be ascertained by using questionnaire to capture socioeconomic details and calculation of concentration index


Information By: Society for Applied Studies

Dates:
Date Received: December 26, 2015
Date Started: November 2015
Date Completion: September 2019
Last Updated: October 6, 2016
Last Verified: December 2015