Kangaroo Mother Care Implementation Research for Accelerating Scale-up

NCT ID: NCT03506698

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3804 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-15

Study Completion Date

2020-02-28

Brief Summary

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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

Detailed Description

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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

Conditions

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Low Birth Weight

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mekelle University

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

Emory University Ethiopia

UNKNOWN

Sponsor Role collaborator

Hawassa University

OTHER

Sponsor Role collaborator

Rajiv Bahl

OTHER

Sponsor Role lead

Responsible Party

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Rajiv Bahl

Study Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Araya Abrha Medhanyie, PhD

Role: PRINCIPAL_INVESTIGATOR

Mekelle University

Abebe Gebremariam Gobezayehu, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Ethiopia

John Cranmer, DNP, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Henok Tadele Dangiso, MD

Role: PRINCIPAL_INVESTIGATOR

Hawassa University

Locations

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Hawassa University Referral Hospital

Awasa, , Ethiopia

Site Status

Felege Hiwot Hospital

Bahir Dar, , Ethiopia

Site Status

Ayder Comprehensive Specialized Hospital

Mek'ele, , Ethiopia

Site Status

Countries

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Ethiopia

References

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Mony PK, Tadele H, Gobezayehu AG, Chan GJ, Kumar A, Mazumder S, Beyene SA, Jayanna K, Kassa DH, Mohammed HA, Estifanos AS, Kumar P, Jadaun AS, Hailu Abay T, Washington M, W/Gebriel F, Alamineh L, Fikre A, Kumar A, Trikha S, Ashebir Gebregizabher F, Kar A, Bilal SM, Belew ML, Debere MK, Krishna R, Dalpath SK, Amare SY, Mohan HL, Brune T, Sibley LM, Tariku A, Sahu A, Kumar T, Hadush MY, Gowda PD, Aziz K, Duguma D, Singh PK, Darmstadt GL, Agarwal R, Gebremariam DS, Martines J, Portela A, Jaiswal HV, Bahl R, Rao Pn S, Tadesse BT, Cranmer JN, Hailemariam D, Kumar V, Bhandari N, Medhanyie AA; KMC Scale-Up Study Group. Scaling up Kangaroo Mother Care in Ethiopia and India: a multi-site implementation research study. BMJ Glob Health. 2021 Sep;6(9):e005905. doi: 10.1136/bmjgh-2021-005905.

Reference Type DERIVED
PMID: 34518203 (View on PubMed)

Medhanyie AA, Alemu H, Asefa A, Beyene SA, Gebregizabher FA, Aziz K, Bhandari N, Beyene H, Brune T, Chan G, Cranmer JN, Darmstadt G, Duguma D, Fikre A, Andualem BG, Gobezayehu AG, Mariam DH, Abay TH, Mohan HL, Jadaun A, Jayanna K, Kajal FNU, Kar A, Krishna R, Kumar A, Kumar V, Madhur TK, Belew ML, M R, Martines J, Mazumder S, Amin H, Mony PK, Muleta M, Pileggi-Castro C, Pn Rao S, Estifanos AS, Sibley LM, Singhal N, Tadele H, Tariku A, Lemango ET, Tadesse BT, Upadhyay R, Worku B, Hadush MY, Bahl R; KMC Scale-Up Study Group. Kangaroo Mother Care implementation research to develop models for accelerating scale-up in India and Ethiopia: study protocol for an adequacy evaluation. BMJ Open. 2019 Nov 21;9(11):e025879. doi: 10.1136/bmjopen-2018-025879.

Reference Type DERIVED
PMID: 31753865 (View on PubMed)

Other Identifiers

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ERC.0002716

Identifier Type: -

Identifier Source: org_study_id

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