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CompletedNCT03419416KMC-OromiaUpdated Jul 16, 2019

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

An observational study in Low Birth-weight, sponsored by Addis Ababa University. Completed at 2 sites in Ethiopia. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Addis Ababa University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
700
Ages
1 Day to 28 Days
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Low Birth-weight

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03

In context

Birth Weight

185 studies on the registry are indexed under Birth Weight; 25 are open to participants now.

This study's enrollment of 700 is above the median of 240 across 63 observational studies indexed under Birth Weight.

Browse Birth Weight studies →

Lead sponsor

Addis Ababa University is the lead sponsor of 19 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All newborns who are less than 2000 gm born within the study facilities during the study period.

Exclusion criteria

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
700 participants (actual)
Target follow-up
28 Days
Patient registry
Yes

Interventions

  • OtherKangaroo mother care (KMC)

    Skin to skin contact of newborns with mothers and exclusive breast feeding

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Seven days of age

07

Study locations

2 sites
  • Tirunesh Beijing Hospital
    Akaki, Addis Ababa, Ethiopia
  • Batu Hospital
    Adami Tulu, Oromia, Ethiopia
08

References and documents

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. PubMed 34518203 ↗
  • 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. PubMed 31753865 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Jun 2019, 24 months.

Of 33 non-industry observational studies under Birth Weight, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's 24 months is close to that.

Counting every sponsor, half of 34 studies reached it within 25 months; a quarter within 10 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 5, 2018
StartActual
Jun 24, 2017
Primary completionActual
Jun 30, 2019
CompletionActual
Jun 30, 2019
Last update
Jul 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03419416
Lead sponsor
Addis Ababa University
Collaborators
Harvard School of Public Health (HSPH), World Health Organization
Responsible party
Damen Haile Mariam (Prof. Damen Haile Mariam, Addis Ababa University) — Principal investigator
First posted
Feb 5, 2018
Start date
Jun 24, 2017
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Jul 16, 2019

Study contacts

Rajiv Bahl, MD, PhD
study director · World Health Organization

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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