Clinical trial NCT03506698: Kangaroo Mother Care Implementation Research for Accelerating Scale-up
Official title: Kangaroo Mother Care Implementation Research for Accelerating Scale-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Birth Weight
Keywords: Birth weight
Lead sponsor: World Health Organization
Sponsor class: OTHER
Collaborators: name: Mekelle University
name: Emory University
name: Emory University Ethiopia
name: Hawassa University
First posted: 2018-04-24
Enrollment: 3804
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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

Detailed description: Kangaroo Mother Care (KMC) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, KMC coverage has remained low and implementation has been limited. The multi-site project includes formative research to identify barriers and contextual factors that affect implementation and utilization of KMC and design scalable models to deliver KMC across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. The aim is to successfully provide KMC to 80% or more of babies born in the study area weighing under 2000 grammes

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.

Primary outcomes:
measure: Effective coverage of KMC at 7 days after discharge
timeFrame: 7 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Bahir Dar
country: Ethiopia
facility: Felege Hiwot Hospital
city: Hawassa
country: Ethiopia
facility: Hawassa University Referral Hospital
city: Mek'ele
country: Ethiopia
facility: Ayder Comprehensive Specialized Hospital
Study officials:
affiliation: Mekelle University
name: Araya Abrha Medhanyie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University Ethiopia
name: Abebe Gebremariam Gobezayehu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: John Cranmer, DNP, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hawassa University
name: Henok Tadele Dangiso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.