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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

Tracking Information
First Submitted Date January 26, 2018
First Posted Date February 5, 2018
Last Update Posted Date July 16, 2019
Actual Study Start Date June 24, 2017
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2018)
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.
Original Primary Outcome Measures
 (submitted: January 26, 2018)
  • 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.
  • Effective coverage of KMC at 7 days after discharge from the facility [ Time Frame: Seven days after discharge from facility ]
    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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia
Official Title KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 28 Days
Biospecimen Not Provided
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.
Condition Low Birth-weight
Intervention Other: Kangaroo mother care (KMC)
Skin to skin contact of newborns with mothers and exclusive breast feeding
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 26, 2018)
700
Original Estimated Enrollment Same as current
Actual Study Completion Date June 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 28 Days   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ethiopia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03419416
Other Study ID Numbers 201523748
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Damen Haile Mariam, Addis Ababa University
Original Responsible Party Same as current
Current Study Sponsor Addis Ababa University
Original Study Sponsor Same as current
Collaborators
  • Harvard School of Public Health (HSPH)
  • World Health Organization
Investigators
Study Director: Rajiv Bahl, MD, PhD World Health Organization
PRS Account Addis Ababa University
Verification Date July 2019