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Community Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns (CKMC-DEV)

Primary Purpose

Low Birth Weight

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
KMC
Essential newborn care
Sponsored by
Society for Applied Studies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Birth Weight focused on measuring Kangaroo mother care in the community

Eligibility Criteria

undefined - 3 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHRD, Society for Applied Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention KMC

Control

Arm Description

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

Routine visits by government health workers

Outcomes

Primary Outcome Measures

Assessment of maternal depression
The depression will be measured using patient health questionnaire-9
Assessment of maternal depression
The depression will be measured using patient health questionnaire-9
Assessment of maternal sense of competence
Maternal sense of competence will be measured by maternal self efficacy questionnaire
Assessment of maternal sense of competence
Maternal sense of competence will be measured by maternal self efficacy questionnaire
Assessment of mother infant bonding
Mother infant bonding will be measured by maternal postnatal attachment questionnaire
Assessment of mother infant interaction
Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task
Assessment of newborn behaviour
Assessment of newborn behaviour by Neonatal behavioural assessment scale
Assessment of infant temperament
Assessment of infant temperament by infant temperament scale
Assessment of infant temperament
Assessment of infant temperament by infant temperament scale
Assessment of cognitive function by Bayley scale
Assessment of cognitive function by Bayley scale
Assessment of home environment by PROCESS

Secondary Outcome Measures

Neonatal mortality
Early infant mortality
Early initiation of breastfeeding
Proportion exclusively breastfed
Weight and length gain
Incidence of infection in neonatal
Early recognition of illness at 1 month
Recognition of illness and careseeking will be ascertained from caregivers by using questionnaires
Early and appropriate care seeking practices at 1 month
Early and appropriate care seeking ascertained from caregivers by using questionnaires
Early recognition of illness at 3 months
Early and appropriate care seeking practices at 3 months
Early recognition of illness at 6 months
Early and appropriate care seeking practices at 6 months

Full Information

First Posted
November 25, 2015
Last Updated
September 5, 2018
Sponsor
Society for Applied Studies
Collaborators
Grand Challenges Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02631343
Brief Title
Community Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Society for Applied Studies
Collaborators
Grand Challenges Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight
Keywords
Kangaroo mother care in the community

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunita Taneja, MBBS, PhD
Organizational Affiliation
Centre for Health Research and Development, Society for Applied Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRD, Society for Applied Studies
City
Palwal
State/Province
Haryana
ZIP/Postal Code
121102
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
36209050
Citation
Upadhyay RP, Taneja S, Strand TA, Sommerfelt H, Hysing M, Mazumder S, Bhandari N, Martines J, Dua T, Kariger P, Bahl R. Early child stimulation, linear growth and neurodevelopment in low birth weight infants. BMC Pediatr. 2022 Oct 8;22(1):586. doi: 10.1186/s12887-022-03579-6.
Results Reference
derived
PubMed Identifier
32247311
Citation
Taneja S, Sinha B, Upadhyay RP, Mazumder S, Sommerfelt H, Martines J, Dalpath SK, Gupta R, Kariger P, Bahl R, Bhandari N, Dua T; ciKMC development study group. Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial. BMC Pediatr. 2020 Apr 4;20(1):150. doi: 10.1186/s12887-020-02046-4.
Results Reference
derived
PubMed Identifier
31590989
Citation
Mazumder S, Taneja S, Dube B, Bhatia K, Ghosh R, Shekhar M, Sinha B, Bahl R, Martines J, Bhan MK, Sommerfelt H, Bhandari N. Effect of community-initiated kangaroo mother care on survival of infants with low birthweight: a randomised controlled trial. Lancet. 2019 Nov 9;394(10210):1724-1736. doi: 10.1016/S0140-6736(19)32223-8. Epub 2019 Oct 4.
Results Reference
derived

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

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