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

• ClinicalTrials.gov Identifier: NCT03419416
• Recruitment Status: Completed
• First Posted: February 5, 2018
• Last Update Posted: July 16, 2019
• Sponsor: Addis Ababa University
• 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.

• 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 *

• 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.

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: 1 Day to 28 Days (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ethiopia

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