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

Completed

• Conditions: Low Birth-weight

• Registration Number: NCT03419416
• Lead Sponsor: Addis Ababa University

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.

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 Timeline

• Study Start: 2017-06-24
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-14
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effective coverage of KMC at 7 days of age.	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.

Trial Locations

Locations (2)

Tirunesh Beijing Hospital; 🇪🇹 Akaki, Addis Ababa, Ethiopia

Batu Hospital; 🇪🇹 Adami Tulu, Oromia, Ethiopia