Hypothermia Prevention in Low Birthweight and Preterm Infants

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 risk for hypothermia, hypoglycemia, infections, and mortality during the first 28 days of life. Kangaroo Mother Care (KMC) has been shown to reduce hypothermia, neonatal infections and neonatal mortality, while improving weight gain and mother-infant attachment; however, implementation to scale has been slow. The BEMPU® bracelet offers the opportunity to monitor the body temperature of newborns for the early detection of hypothermia and to increase the uptake of KMC. Further research is needed to evaluate the impact of the BEMPU® bracelet on KMC practices and neonatal health outcomes and facilitate its adoption in low-resource settings. The goal of this research is to evaluate its effect on KMC practices and neonatal health outcomes in Ghana. Evidence of a significant impact on outcomes will provide critical evidence to facilitate prompt identification of hypothermia, maximize the benefits of KMC, decrease the risk of neonatal death, and impact the leading cause of neonatal mortality in Ghana and other settings.

Conditions

• Neonatal Hypothermia

Interventions

OTHER

Kangaroo Mother Care and BEMPU bracelet

Kangaroo mother care involves early, continuous and prolonged skin-to-skin contact between a mother and her newborn, frequent and exclusive breastfeeding and early discharge from hospital. The BEMPU bracelet, also known as the BEMPU Tempwatch, is a silicone band with a thermistor metal cup that emits an audio alarm and flashes an orange light when the body temperature drops below 36.5⁰C, signaling hypothermia and prompting caregiver to provide thermal care.

OTHER

Kangaroo Mother Care

Kangaroo mother care involves early, continuous and prolonged skin-to-skin contact between a mother and her newborn, frequent and exclusive breastfeeding and early discharge from hospital. This is the current standard of care for low birthweight/preterm infants.

Sponsors & Collaborators

• Centre for Learning and Childhood Development - Ghana

  collaborator UNKNOWN

• Ghana Health Services

  collaborator OTHER_GOV

• Korle-Bu Teaching Hospital, Accra, Ghana

  collaborator OTHER

• University of South Carolina

  lead OTHER

Principal Investigators

• Mufaro Kanyangarara · University of South Carolina

• Prince Owusu · Centre for Learning and Childhood Development - Ghana

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

28 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Ghana

Study Locations