Kangaroo Mother Care Implementation Research for Accelerating Scale-up

NCT03506698 | Completed

• 1 other identifier: ERC.0002716
• Study Type: observational
• Target: 3,804
• Locations: 1 country
• Sites: 3

Brief Summary

The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage

Conditions

Low Birth Weight

Keywords

Birth weight

Outcome Measures

Primary Outcomes (1)

• Effective coverage of KMC at 7 days after discharge

  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

  7 days after discharge

Interventions

Kangaroo Mother Care (KMC) OTHER

Skin to skin contact of newborns with mothers or caregiver for a minimum of at least eight hours over a 24-hours period, along with exclusive breastfeeding or breast milk feeding via tube or spoon

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

newborn babies with birth weight less than 2000gm born in the geographic area targeted by the intervention, including all babies born in health facilities and in the community

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.

Sponsors & Collaborators

• Rajiv Bahl: lead
• Mekelle University: collaborator
• Emory University: collaborator
• Emory University Ethiopia: collaborator
• Hawassa University: collaborator

Study Sites (3)

Hawassa University Referral Hospital

Awasa, Ethiopia

Location

Felege Hiwot Hospital

Bahir Dar, Ethiopia

Location

Ayder Comprehensive Specialized Hospital

Mek'ele, 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: 34518203 DERIVED

• 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: 31753865 DERIVED

MeSH Terms

Conditions

Birth Weight

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Araya Abrha Medhanyie, PhD

  Mekelle University

  PRINCIPAL INVESTIGATOR

• Abebe Gebremariam Gobezayehu, MD

  Emory University Ethiopia

  PRINCIPAL INVESTIGATOR

• John Cranmer, DNP, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

• Henok Tadele Dangiso, MD

  Hawassa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 24, 2018
• Study Start: June 15, 2017
• Primary Completion: May 30, 2019
• Study Completion: February 28, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ET (3)