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

Low Birth-weight Clinical Trial

— KMC-Oromia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419416
• Other study ID #: 201523748
• Status: Completed
• Start date: June 24, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Addis Ababa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Low Birth-weight

Intervention

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

Locations

Country	Name	City	State
Ethiopia	Batu Hospital	Adami Tulu	Oromia
Ethiopia	Tirunesh Beijing Hospital	Akaki	Addis Ababa

Sponsors (3)

Lead Sponsor	Collaborator
Addis Ababa University	Harvard School of Public Health, World Health Organization

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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