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

Study Overview
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Brief Summary
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This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) 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. The data safety and monitoring committee (DSMC) conducted two interim analyses, first in September 2017 when about half of the infants had been enrolled, and second in June 2018, when almost three quarters of the enrolled babies had been followed till 28 days of age. Following the second interim analysis, the DSMC concluded that a sufficient number of infants would be enrolled by the end to September 2018 to clearly answer the study question concerning the impact of ciKMC on both neonatal and early infant mortality. The DSMC recommended that data collection be completed by the end of October 2018.

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

Conditions
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Low-Birth-Weight

Intervention / Treatment
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* Behavioral: Kangaroo Mother Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low birth weight babies (≥1500 to ≤2250 g) screened within 3 days and their mothers. Born at home Singleton or twins or triplets Infants born in hospital, discharged and KMC not initiated in the hospital Exclusion Criteria: Infant unable to feed Infant has breathing problem Infant is less active than normal Gross congenital malformations Mother does not intend to stay in the study area for the next 6 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 Kangaroo Mother Care<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: Kangaroo Mother Care<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>|
| No Intervention: Control<br>Routine visits by government health workers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal mortality from post enrolment to 28 days |  | From post enrolment to 28 days | 
| Early infant mortality from post enrolment to 6 months of age |  | From post enrolment to 6 months | 

Secondary Outcome Measures

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