NCT03419416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

January 26, 2018

Last Update Submit

July 14, 2019

Conditions

Low Birth-weight

Outcome Measures

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.

    Seven days of age

Interventions

Kangaroo mother care (KMC)OTHER

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

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tirunesh Beijing Hospital

Akaki, Addis Ababa, Ethiopia

Location

Batu Hospital

Ādamī Tulu, Oromiya, Ethiopia

Location

Related Publications (2)

  • 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.

    PMID: 34518203DERIVED

  • 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.

    PMID: 31753865DERIVED

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rajiv Bahl, MD, PhD

    World Health Organization

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Damen Haile Mariam

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 5, 2018

Study Start

June 24, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

ET(2)