Low Birth Weight
Conditions
Keywords
Kangaroo mother care in the community
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.
Interventions
BEHAVIORALKMC
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
OTHEREssential newborn care
Sponsors
Grand Challenges Canada
Society for Applied Studies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of maternal depression | 6 weeks | The depression will be measured using patient health questionnaire-9 |
| Assessment of maternal sense of competence | 6 weeks | Maternal sense of competence will be measured by maternal self efficacy questionnaire |
| Assessment of mother infant bonding | 6 weeks | Mother infant bonding will be measured by maternal postnatal attachment questionnaire |
| 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 newborn behaviour | 6 weeks | Assessment of newborn behaviour by Neonatal behavioural assessment scale |
| Assessment of infant temperament | 6 months | Assessment of infant temperament by infant temperament scale |
| Assessment of cognitive function by Bayley scale | 6 months | — |
| Assessment of home environment by PROCESS | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Neonatal mortality | From birth to 28 days | — |
| Early and appropriate care seeking practices at 6 months | Assessed at 6 months data from 3 months upto 6 months | — |
| Early recognition of illness at 6 months | Assessed at 6 months data from 3 months upto 6 months | — |
| 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 | 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 | 1 month period | Early and appropriate care seeking ascertained from caregivers by using questionnaires |
Countries
India
Outcome results
None listed