Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Layout table for study information
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


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


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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
Layout table for location information
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
Layout table for investigator information
Study Director: Rajiv Bahl, MD, PhD World Health Organization
Additional Information:

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

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Birth Weight
Body Weight