Status:

UNKNOWN

Hypothermia Prevention in Low Birthweight and Preterm Infants

Lead Sponsor:

University of South Carolina

Collaborating Sponsors:

Centre for Learning and Childhood Development - Ghana

Ghana Health Services

Conditions:

Neonatal Hypothermia

Eligibility:

All Genders

Up to 28 years

Phase:

NA

Brief Summary

Preterm birth complications are the leading cause of neonatal mortality and account for over one million neonatal deaths annually. About 12% of babies are born before 37 weeks of gestation, and are at...

Detailed Description

This study will evaluate the effect of the bracelet on KMC practices and neonatal health outcomes in LBW infants using a randomized controlled trial. Infants currently being treated in the KMC or neon...

Eligibility Criteria

Inclusion

  • Currently being treated in the KMC or neonatal ward at one of the participating hospitals
  • Age\<28 days
  • Weight \<2,500 grams at birth
  • Clinically stable
  • Mother is available, willing and able to provide consent

Exclusion

  • Clinically unstable
  • Twin or multiple birth
  • Ineligible to initiate KMC
  • Mother \<18 years of age
  • Residence outside health facility catchment area or intention to relocate during the four weeks following discharge

Key Trial Info

Start Date :

January 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2022

Estimated Enrollment :

380 Patients enrolled

Trial Details

Trial ID

NCT04364204

Start Date

January 1 2022

End Date

December 31 2022

Last Update

October 5 2021

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Achimota General Hospital

Accra, Ghana

2

Greater Accra Regional Hospital

Accra, Ghana

3

Korle-Bu Teaching Hospital

Accra, Ghana

4

Princess Marie Luis Children's Hospital

Accra, Ghana