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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
550
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
CHRD, Society for Applied Studies
Palwal, Haryana, India
Assessment of maternal depression
The depression will be measured using patient health questionnaire-9
Time frame: 6 weeks
Assessment of maternal depression
The depression will be measured using patient health questionnaire-9
Time frame: Assessment of maternal depression at 6 months
Assessment of maternal sense of competence
Maternal sense of competence will be measured by maternal self efficacy questionnaire
Time frame: 6 weeks
Assessment of maternal sense of competence
Maternal sense of competence will be measured by maternal self efficacy questionnaire
Time frame: Assessment of maternal sense of competence at 12 months
Assessment of mother infant bonding
Mother infant bonding will be measured by maternal postnatal attachment questionnaire
Time frame: 6 weeks
Assessment of mother infant interaction
Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task
Time frame: 6 months
Assessment of newborn behaviour
Assessment of newborn behaviour by Neonatal behavioural assessment scale
Time frame: 6 weeks
Assessment of infant temperament
Assessment of infant temperament by infant temperament scale
Time frame: 6 months
Assessment of infant temperament
Assessment of infant temperament by infant temperament scale
Time frame: Assessment of infant temperament at 12 months
Assessment of cognitive function by Bayley scale
Time frame: 6 months
Assessment of cognitive function by Bayley scale
Time frame: Assessment of cognitive function by Bayley scale at 12 months
Assessment of home environment by PROCESS
Time frame: 12 months
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
Recognition of illness and careseeking will be ascertained from caregivers by using questionnaires
Time frame: 1 month period
Early and appropriate care seeking practices at 1 month
Early and appropriate care seeking ascertained from caregivers by using questionnaires
Time frame: 1 month period
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
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Time frame: Assessed at 6 months data from 3 months upto 6 months