Community Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns
- Conditions
- Low Birth Weight
- Interventions
- Other: Essential newborn careBehavioral: KMC
- Registration Number
- NCT02631343
- Lead Sponsor
- Society for Applied Studies
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 550
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Essential newborn care Routine visits by government health workers Intervention KMC KMC Promotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers Intervention KMC Essential newborn care Promotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers
- Primary Outcome Measures
Name Time Method Assessment of maternal sense of competence Assessment of maternal sense of competence at 12 months Maternal sense of competence will be measured by maternal self efficacy questionnaire
Assessment of newborn behaviour 6 weeks Assessment of newborn behaviour by Neonatal behavioural assessment scale
Assessment of mother infant interaction 6 months Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task
Assessment of cognitive function by Bayley scale Assessment of cognitive function by Bayley scale at 12 months Assessment of home environment by PROCESS 12 months Assessment of maternal depression Assessment of maternal depression at 6 months The depression will be measured using patient health questionnaire-9
Assessment of mother infant bonding 6 weeks Mother infant bonding will be measured by maternal postnatal attachment questionnaire
Assessment of infant temperament Assessment of infant temperament at 12 months Assessment of infant temperament by infant temperament scale
- Secondary Outcome Measures
Name Time Method Early initiation of breastfeeding From birth to 1 month Early and appropriate care seeking practices at 3 months Assessed at 3 months data from 1 month upto 3 months Neonatal mortality From birth to 28 days Early recognition of illness at 3 months Assessed at 3 months data from 1 month upto 3 months Early and appropriate care seeking practices at 1 month 1 month period Early and appropriate care seeking ascertained from caregivers by using questionnaires
Early recognition of illness at 1 month 1 month period Recognition of illness and careseeking will be ascertained from caregivers by using questionnaires
Early infant mortality From birth to 6 months Proportion exclusively breastfed 1, 3 and 6 months Incidence of infection in neonatal 1 month period Early recognition of illness at 6 months Assessed at 6 months data from 3 months upto 6 months Early and appropriate care seeking practices at 6 months Assessed at 6 months data from 3 months upto 6 months Weight and length gain 1, 3, 6 and 12 months
Trial Locations
- Locations (1)
CHRD, Society for Applied Studies
🇮🇳Palwal, Haryana, India