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

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.

Study Overview

• Status: Completed
• Conditions: Low Birth-weight
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective coverage of KMC at 7 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.	Seven days of age

Collaborators and Investigators

• Sponsor: Addis Ababa University
• Collaborators: World Health Organization; Harvard School of Public Health (HSPH)
• Investigators: Study Director: Rajiv Bahl, MD, PhD, World Health Organization

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 201523748

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No