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Kangaroo Mother Care Implementation Research for Accelerating Scale-up

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ClinicalTrials.gov Identifier: NCT03506698
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Mekelle University
Emory University
Emory University Ethiopia
Hawassa University
Information provided by (Responsible Party):
Rajiv Bahl, World Health Organization

Brief Summary:
The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage

Condition or disease Intervention/treatment
Low Birth Weight Other: Kangaroo Mother Care (KMC)

Detailed Description:
Kangaroo Mother Care (KMC) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, KMC coverage has remained low and implementation has been limited. The multi-site project includes formative research to identify barriers and contextual factors that affect implementation and utilization of KMC and design scalable models to deliver KMC across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. The aim is to successfully provide KMC to 80% or more of babies born in the study area weighing under 2000 grammes

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Study Type : Observational
Actual Enrollment : 3804 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Kangaroo Mother Care Implementation Research for Accelerating Scale-up
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Kangaroo Mother Care (KMC)
    Skin to skin contact of newborns with mothers or caregiver for a minimum of at least eight hours over a 24-hours period, along with exclusive breastfeeding or breast milk feeding via tube or spoon


Primary Outcome Measures :
  1. Effective coverage of KMC at 7 days after discharge [ Time Frame: 7 days after discharge ]
    Effective coverage will be defined as adoption of skin-to-skin care for at least 8 hours and exclusive breastfeeding in the 24 hours prior to assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
newborn babies with birth weight less than 2000gm born in the geographic area targeted by the intervention, including all babies born in health facilities and in the community
Criteria

Inclusion Criteria:

• All newborns who are less than 2000 gm born within the study facilities during the study period.

Exclusion Criteria:

• Newborns who are sick per predefined criteria will not be provided KMC until they have been stabilized. Criteria for delay of initiation include: critical illness including apnea, decreased respiratory rate <20 breaths per minute, grunting, cyanosis, severe chest in-drawing, convulsions, unconsciousness, and severe hypothermia <32°F.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506698


Locations
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Ethiopia
Felege Hiwot Hospital
Bahir Dar, Ethiopia
Hawassa University Referral Hospital
Hawassa, Ethiopia
Ayder Comprehensive Specialized Hospital
Mek'ele, Ethiopia
Sponsors and Collaborators
Rajiv Bahl
Mekelle University
Emory University
Emory University Ethiopia
Hawassa University
Investigators
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Principal Investigator: Araya Abrha Medhanyie, PhD Mekelle University
Principal Investigator: Abebe Gebremariam Gobezayehu, MD Emory University Ethiopia
Principal Investigator: John Cranmer, DNP, MPH Emory University
Principal Investigator: Henok Tadele Dangiso, MD Hawassa University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rajiv Bahl, Study Director, World Health Organization
ClinicalTrials.gov Identifier: NCT03506698    
Other Study ID Numbers: ERC.0002716
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajiv Bahl, World Health Organization:
Birth weight
Additional relevant MeSH terms:
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Birth Weight
Body Weight