KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia (KMC-Oromia)
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ClinicalTrials.gov Identifier: NCT03419416 |
Recruitment Status :
Completed
First Posted : February 5, 2018
Last Update Posted : July 16, 2019
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Condition or disease | Intervention/treatment |
---|---|
Low Birth-weight | Other: Kangaroo mother care (KMC) |
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] |
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 |

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

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Ages Eligible for Study: | up to 28 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
Ethiopia | |
Tirunesh Beijing Hospital | |
Akaki, Addis Ababa, Ethiopia | |
Batu Hospital | |
Adami Tulu, Oromia, Ethiopia |
Study Director: | Rajiv Bahl, MD, PhD | World Health Organization |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Birth Weight Body Weight |