Clinical Trial: Community Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns

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

Official Title: A Community-based Model of Delivery of Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns

Brief Summary:

While newborn and child survival remains a priority, optimal development of survivors is receiving increasing attention. Interventions that impact both survival and development should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and potentially neurodevelopment, in preterm and low birth weight infants in hospital settings but its coverage remains low. Innovation is required to allow the community-based delivery of KMC by front-line workers. This could greatly accelerate scale up and sustainability of this intervention in low resource settings.

The proposed randomized trial is planned in a setting where 40% of births take place at home. Early discharge (as early as within 12 hours of birth) is common for facility births, often at the request of families for social and cultural reasons. Many of the hospitals do not have incubators for the care of very small babies.


Detailed Summary: Low birth weight (LBW) infants will be identified through surveillance. Eligible infants will be randomized into the intervention and control groups. Mother in the intervention group will be supported by a ANM-like study workers assisted by ASHA-like study workers to provide Kangaroo mother care (KMC) to their babies at home. Breastfeeding support will also be provided to these mothers by ANM-like study workers. Essential newborn care will be delivered through Government workers in both groups. Survival will be measured in all enrolled infants through contacts at 1, 3, 6 and 12 months of age. Information will also be ascertained on initiation of breastfeeding, exclusive breastfeeding rates, incidence of infection in the neonatal and in the 1-5 months period. Development outcomes (Maternal Depression, Maternal sense of competence, Mother-infant Bonding, Mother-infant interaction, Newborn Behaviour, Infant temperament, Brain development) will be measured at enrolment, 6weeks, 6 and 12 months of age. Growth will be measured at enrolment and at 1, 3, 6 and 12 months.
Sponsor: Society for Applied Studies

Current Primary Outcome:

  • Assessment of maternal depression [ Time Frame: 6 weeks ]
    The depression will be measured using patient health questionnaire-9
  • Assessment of maternal depression [ Time Frame: Assessment of maternal depression at 6 months ]
    The depression will be measured using patient health questionnaire-9
  • Assessment of maternal sense of competence [ Time Frame: 6 weeks ]
    Maternal sense of competence will be measured by maternal self efficacy questionnaire
  • Assessment of maternal sense of competence [ Time Frame: Assessment of maternal sense of competence at 12 months ]
    Maternal sense of competence will be measured by maternal self efficacy questionnaire
  • Assessment of mother infant bonding [ Time Frame: 6 weeks ]
    Mother infant bonding will be measured by maternal postnatal attachment questionnaire
  • Assessment of mother infant interaction [ Time Frame: 6 months ]
    Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task
  • Assessment of newborn behaviour [ Time Frame: 6 weeks ]
    Assessment of newborn behaviour by Neonatal behavioural assessment scale
  • Assessment of infant temperament [ Time Frame: 6 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Neonatal mortality [ Time Frame: From birth to 28 days ]
    • Early infant mortality [ Time Frame: From birth to 6 months ]
    • Early initiation of breastfeeding [ Time Frame: From birth to 1 month ]
    • Proportion exclusively breastfed [ Time Frame: 1, 3 and 6 months ]
    • Weight and length gain [ Time Frame: 1, 3, 6 and 12 months ]
    • Incidence of infection in neonatal [ Time Frame: 1 month period ]
    • Early recognition of illness at 1 month [ Time Frame: 1 month period ]
      Recognition of illness and careseeking will be ascertained from caregivers by using questionnaires
    • Early and appropriate care seeking practices at 1 month [ Time Frame: 1 month period ]
      Early and appropriate care seeking ascertained from caregivers by using questionnaires
    • Early recognition of illness at 3 months [ Time Frame: Assessed at 3 months data from 1 month upto 3 months ]
    • Early and appropriate care seeking practices at 3 months [ Time Frame: Assessed at 3 months data from 1 month upto 3 months ]
    • Early recognition of illness at 6 months [ Time Frame: Assessed at 6 months data from 3 months upto 6 months ]
    • Early and appropriate care seeking practices at 6 months [ Time Frame: Assessed at 6 months data from 3 months upto 6 months ]


    Original Secondary Outcome: Same as current

    Information By: Society for Applied Studies

    Dates:
    Date Received: November 25, 2015
    Date Started: December 2015
    Date Completion: May 2017
    Last Updated: February 16, 2016
    Last Verified: December 2015