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Completed

NCT Number: NCT03506698

Kangaroo Mother Care Implementation Research for Accelerating Scale-up

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

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Key information

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Hawassa University Referral Hospital, Awasa, Ethiopia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Effective coverage of KMC at 7 days after discharge

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rajiv Bahl

Other

Collaborators

  • Emory University
  • Emory University Ethiopia
  • Hawassa University
  • Mekelle University

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2018
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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