KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia (KMC-Oromia)

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ClinicalTrials.gov Identifier: NCT03419416

Recruitment Status : Completed

First Posted : February 5, 2018

Last Update Posted : July 16, 2019

Sponsor:

Collaborators:

Harvard School of Public Health (HSPH)

World Health Organization

Information provided by (Responsible Party):

Damen Haile Mariam, Addis Ababa University

Study Description

Brief Summary:

The main objective is to implement Kangaroo Mother Care (KMC) at selected facilities in Addis Ababa and Oromia Regions to achieve high effective coverage in the catchment population.

Condition or disease	Intervention/treatment
Low Birth-weight	Other: Kangaroo mother care (KMC)

Detailed Description:

To achieve the objective summarized above, the investigators will engage in an iterative process using program learning and quantitative data to continuously improve models in order to enhance uptake of KMC in two phases.

In phase 1, the model will undergo an iterative process whereby every three months, the investigators will analyze the data collected and improve the model until it is reached at a model that achieves effective KMC coverage of at least 80%.

In phase 2, we will scale the successful model to all selected facilities.

The investigators' primary outcomes will be effective coverage of KMC at 7 days of age, and effective coverage of KMC at 7 days after discharge from the facility. Effective coverage will be defined as adoption of skin to skin care for at 8 least hours and exclusive breastfeeding in the 24 hours prior to assessment

Study Design

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Study Type :	Observational [Patient Registry]
Actual Enrollment :	700 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Target Follow-Up Duration:	28 Days
Official Title:	KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia
Actual Study Start Date :	June 24, 2017
Actual Primary Completion Date :	June 30, 2019
Actual Study Completion Date :	June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

Other: Kangaroo mother care (KMC)
Skin to skin contact of newborns with mothers and exclusive breast feeding

Outcome Measures

Primary Outcome Measures :

Effective coverage of KMC at 7 days of age. [ Time Frame: Seven days of age ]
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.

Eligibility Criteria

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

The study population will be low birth weight babies (less than 2000 gm) within the study sites. The study sites are one primary hospital in Addis Ababa Region and two primary and one referral hospital in Oromia Region.

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.

Contacts and Locations

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): NCT03419416

Locations

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Ethiopia
Tirunesh Beijing Hospital
Akaki, Addis Ababa, Ethiopia
Batu Hospital
Adami Tulu, Oromia, Ethiopia

Sponsors and Collaborators

Addis Ababa University

Harvard School of Public Health (HSPH)

World Health Organization

Investigators

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Study Director:	Rajiv Bahl, MD, PhD	World Health Organization

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: e005905. doi: 10.1136/bmjgh-2021-005905.

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.

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Responsible Party:	Damen Haile Mariam, Prof. Damen Haile Mariam, Addis Ababa University
ClinicalTrials.gov Identifier:	NCT03419416
Other Study ID Numbers:	201523748
First Posted:	February 5, 2018 Key Record Dates
Last Update Posted:	July 16, 2019
Last Verified:	July 2019

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Birth Weight Body Weight

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