Hypothermia Prevention in Low Birthweight and Preterm Infants

NCT ID: NCT04364204

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-12-31

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 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.

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 neonatal wards of the participating hospitals will be screened for eligibility by study nurses. After obtaining parental consent, infants will be randomly assigned with a 1:1 ratio to KMC with and without the BEMPU® bracelet.

A standardized questionnaire will be administered to each mother to collect information on socio-demographic characteristics and contact information. As is the standard of care, all mothers regardless of study arm will be taught how to provide KMC, how to monitor the infant's condition and recognize dangerous clinical signs during KMC and will be supported by a nurse during initial attempts at practicing KMC.

Mothers of infants randomly allocated to the intervention arm will be taught to use the bracelet. The meaning of the audiovisual alarm will be explained as well as the measures to be taken if the device indicates any sign of hypothermia. There will not be any additional training beyond that pertaining to the BEMPU® bracelet. The study nurse will then place the BEMPU® bracelet on the wrist of the infant. Infants in the intervention arm will wear the bracelet for up to 28 days post-discharge.

After discharge, participants in both the intervention and control arms will receive two study visits; one at 7 days post discharge and one at 28 days post-discharge. During each visit, infants will receive a physical examination to collect weight, length, head circumference and axillary temperature, and additional data will be collected on history of illnesses, care-seeking and treatment, KMC and feeding practices, and frequency of use of the bracelet (if applicable).

Conditions

Neonatal Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Kangaroo mother care with bracelet

Group Type: EXPERIMENTAL

Kangaroo Mother Care and BEMPU bracelet

Intervention Type: OTHER

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.

Kangaroo mother care

Group Type: ACTIVE_COMPARATOR

Kangaroo Mother Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Learning and Childhood Development - Ghana

UNKNOWN

Sponsor Role: collaborator

Ghana Health Services

OTHER_GOV

Sponsor Role: collaborator

Korle-Bu Teaching Hospital, Accra, Ghana

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Mufaro Kanyangarara

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mufaro Kanyangarara

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Prince Owusu

Role: PRINCIPAL_INVESTIGATOR

Centre for Learning and Childhood Development - Ghana

Locations

Achimota General Hospital

Accra, , Ghana

Greater Accra Regional Hospital

Accra, , Ghana

Korle-Bu Teaching Hospital

Accra, , Ghana

Princess Marie Luis Children's Hospital

Accra, , Ghana

Central Regional Hospital

Cape Coast, , Ghana

Eastern Regional Hospital

Koforidua, , Ghana

Countries

Ghana

Central Contacts

Mufaro Kanyangarara

Role: CONTACT

mufaro@mailbox.sc.edu

8037777562

Facility Contacts

Prince Owusu

Role: primary

Prince Owusu

Role: primary

Prince Owusu

Role: primary

Prince Owusu

Role: primary

Prince Owusu

Role: primary

Prince Owusu

Role: primary

Other Identifiers

Pro00095600

Identifier Type: -

Identifier Source: org_study_id