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

Low Birth Weight Clinical Trial

— CKMC-DEV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631343
• Other study ID #: 0725-03
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: September 2018
• Source: Society for Applied Studies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Low Birth Weight

Intervention

Behavioral:
• 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

Other:
• Essential newborn care

Locations

Country	Name	City	State
India	CHRD, Society for Applied Studies	Palwal	Haryana

Sponsors (2)

Lead Sponsor	Collaborator
Society for Applied Studies	Grand Challenges Canada

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of maternal depression	The depression will be measured using patient health questionnaire-9	6 weeks
Primary	Assessment of maternal depression	The depression will be measured using patient health questionnaire-9	Assessment of maternal depression at 6 months
Primary	Assessment of maternal sense of competence	Maternal sense of competence will be measured by maternal self efficacy questionnaire	6 weeks
Primary	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
Primary	Assessment of mother infant bonding	Mother infant bonding will be measured by maternal postnatal attachment questionnaire	6 weeks
Primary	Assessment of mother infant interaction	Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task	6 months
Primary	Assessment of newborn behaviour	Assessment of newborn behaviour by Neonatal behavioural assessment scale	6 weeks
Primary	Assessment of infant temperament	Assessment of infant temperament by infant temperament scale	6 months
Primary	Assessment of infant temperament	Assessment of infant temperament by infant temperament scale	Assessment of infant temperament at 12 months
Primary	Assessment of cognitive function by Bayley scale		6 months
Primary	Assessment of cognitive function by Bayley scale		Assessment of cognitive function by Bayley scale at 12 months
Primary	Assessment of home environment by PROCESS		12 months
Secondary	Neonatal mortality		From birth to 28 days
Secondary	Early infant mortality		From birth to 6 months
Secondary	Early initiation of breastfeeding		From birth to 1 month
Secondary	Proportion exclusively breastfed		1, 3 and 6 months
Secondary	Weight and length gain		1, 3, 6 and 12 months
Secondary	Incidence of infection in neonatal		1 month period
Secondary	Early recognition of illness at 1 month	Recognition of illness and careseeking will be ascertained from caregivers by using questionnaires	1 month period
Secondary	Early and appropriate care seeking practices at 1 month	Early and appropriate care seeking ascertained from caregivers by using questionnaires	1 month period
Secondary	Early recognition of illness at 3 months		Assessed at 3 months data from 1 month upto 3 months
Secondary	Early and appropriate care seeking practices at 3 months		Assessed at 3 months data from 1 month upto 3 months
Secondary	Early recognition of illness at 6 months		Assessed at 6 months data from 3 months upto 6 months
Secondary	Early and appropriate care seeking practices at 6 months		Assessed at 6 months data from 3 months upto 6 months