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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2015 by Society for Applied Studies
Sponsor:
Collaborator:
Centre For International Health
Information provided by (Responsible Party):
Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT02653534
First received: December 26, 2015
Last updated: October 6, 2016
Last verified: December 2015
  Purpose

This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (KMC) 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.


Condition Intervention
Low-Birth-Weight Behavioral: Kangaroo Mother Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • Neonatal mortality from post enrolment to 28 days [ Time Frame: From post enrolment to 28 days ]
  • Early infant mortality from post enrolment to 6 months of age [ Time Frame: From post enrolment to 6 months ]

Secondary Outcome Measures:
  • Proportion exclusively breastfed at 1 and 3 months [ Time Frame: 1 month, 3 months ]
  • Weight gain [ Time Frame: 1, 3 and 6 months ]
  • Length gain [ Time Frame: 1, 3 and 6 months ]
  • Incidence of infection and hospitalization [ Time Frame: 1 month and 1 to 5 months ]
  • Early recognition of illness at 1 month [ Time Frame: 1 month period ]
    Recognition of illness will be ascertained from caregivers by using questionnaire

  • Early appropriate care seeking practices at 1 month [ Time Frame: 1 month period ]
    Early appropriate care seeking ascertained from caregivers by using questionnaire

  • Early recognition of illness at 3 months [ Time Frame: Assessed at 3 months, data from 1 month upto 3 months ]
    Recognition of illness ascertained from caregivers by using questionnaire

  • Early appropriate care seeking practices at 3 months [ Time Frame: Assessed at 3 months, data from 1 month upto 3 months ]
    Early appropriate care-seeking ascertained from caregivers by using questionnaire

  • Early recognition of illness at 6 months [ Time Frame: Assessed at 6 months, data from 3 months upto 6 months ]
    Recognition of illness ascertained from caregivers by using questionnaire

  • Early appropriate care seeking practices at 6 months [ Time Frame: Assessed at 6 months, data from 3 months upto 6 months ]
    Early appropriate care-seeking practices ascertained by using questionnaire

  • Assessment of cognitive function by Bayley scale in a subsample [ Time Frame: Assessment of cognitive function by Bayley scale at 6 months ]
  • Assessment of cognitive function by Bayley scale in a subsample [ Time Frame: Assessment of cognitive function by Bayley scale at 12 months ]
  • Head circumference [ Time Frame: 1, 3 and 6 months ]

Estimated Enrollment: 10500
Study Start Date: November 2015
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention 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
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
No Intervention: Control
Routine visits by government health workers

  Eligibility

Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02653534

Contacts
Contact: Dr. Sarmila Mazumder, MBBS, PhD +91 11-46043751-55 ext 401 CHRD@sas.org.in
Contact: Dr. Sunita Taneja, MBBS, PhD +91 11-46043751-55 ext 301 CHRD@sas.org.in

Locations
India
CHRD, Society for Applied Studies Recruiting
Palwal, Haryana, India, 121102
Contact: Dr. Sarmila Mazumder, MBBS, PhD    +9111-46043751-55 ext 401    CHRD@sas.org.in   
Contact: Dr. Sunita Taneja, MBBS, PhD    +9111-46043751-55 ext 301    CHRD@sas.org.in   
Sponsors and Collaborators
Society for Applied Studies
Centre For International Health
Investigators
Principal Investigator: Dr. Sarmila Mazumder, MBBS, PhD Society for Applied Studies
  More Information

Responsible Party: Society for Applied Studies
ClinicalTrials.gov Identifier: NCT02653534     History of Changes
Other Study ID Numbers: 2015/1486/REK vest
Study First Received: December 26, 2015
Last Updated: October 6, 2016

Keywords provided by Society for Applied Studies:
Kangaroo Mother Care in community
mortality

Additional relevant MeSH terms:
Body Weight
Birth Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 21, 2017