Kangaroo Mother Care Implementation Research for Accelerating Scale-up

Low Birth Weight Clinical Trial

Official title:

Kangaroo Mother Care Implementation Research for Accelerating Scale-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506698
• Other study ID #: ERC.0002716
• Status: Completed
• Start date: June 15, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2021
• Source: World Health Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3804
• Est. completion date: February 28, 2020
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Low Birth Weight

Intervention

Other:
• Kangaroo Mother Care (KMC)
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

Locations

Country	Name	City	State
Ethiopia	Felege Hiwot Hospital	Bahir Dar
Ethiopia	Hawassa University Referral Hospital	Hawassa
Ethiopia	Ayder Comprehensive Specialized Hospital	Mek'ele

Sponsors (5)

Lead Sponsor	Collaborator
Rajiv Bahl	Emory University, Emory University Ethiopia, Hawassa University, Mekelle University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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