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

Low-Birth-Weight Clinical Trial

— KMC-LBW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653534
• Other study ID #: 2015/1486/REK vest
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: October 2018

Study information

• Verified date: December 2015
• Source: Society for Applied Studies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8402
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Low-Birth-Weight

Intervention

Behavioral:
• Kangaroo Mother Care
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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Society for Applied Studies	Centre For International Health

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal mortality from post enrolment to 28 days		From post enrolment to 28 days
Primary	Early infant mortality from post enrolment to 6 months of age		From post enrolment to 6 months
Secondary	Proportion exclusively breastfed at 1 and 3 months		1 month, 3 months
Secondary	Weight gain		1, 3 and 6 months
Secondary	Length gain		1, 3 and 6 months
Secondary	Incidence of infection and hospitalization		1 month and 1 to 5 months
Secondary	Early recognition of illness at 1 month	Recognition of illness will be ascertained from caregivers by using questionnaire	1 month period
Secondary	Early appropriate care seeking practices at 1 month	Early appropriate care seeking ascertained from caregivers by using questionnaire	1 month period
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of cognitive function by Bayley scale in a subsample		Assessment of cognitive function by Bayley scale at 6 months
Secondary	Assessment of cognitive function by Bayley scale in a subsample		Assessment of cognitive function by Bayley scale at 12 months
Secondary	Head circumference		1, 3 and 6 months