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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Birth Weight

Intervention / Treatment
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* Behavioral: KMC
* Other: Essential newborn care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria - Mothers and low birth weight ≥1500gms to ≤2250gms Exclusion criteria Birth weight <1500gms Unable to feed on offering feeds, confirmed by study team Infant has breathing problems or less active Mother does not intend to stay in study area for the next 12 months

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention KMC<br>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 | Behavioral: KMC<br>* 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<br>Other: Essential newborn care<br> <br> |
| Other: Control<br>Routine visits by government health workers | Other: Essential newborn care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of maternal depression | The depression will be measured using patient health questionnaire-9 | 6 weeks | 
| Assessment of maternal depression | The depression will be measured using patient health questionnaire-9 | 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 | 6 weeks | 
| Assessment of maternal sense of competence | Maternal sense of competence will be measured by maternal self efficacy questionnaire | 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 | 6 weeks | 
| Assessment of mother infant interaction | Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task | 6 months | 
| Assessment of newborn behaviour | Assessment of newborn behaviour by Neonatal behavioural assessment scale | 6 weeks | 
| Assessment of infant temperament | Assessment of infant temperament by infant temperament scale | 6 months | 
| Assessment of infant temperament | Assessment of infant temperament by infant temperament scale | Assessment of infant temperament at 12 months | 
| Assessment of cognitive function by Bayley scale |  | 6 months | 
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kangaroo mother care in the community