Hypothermia Prevention in Low Birthweight and Preterm Infants

Neonatal Hypothermia Clinical Trial

Official title:

Hypothermia Prevention in Low Birthweight and Preterm Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04364204
• Other study ID #: Pro00095600
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: University of South Carolina
• Contact: Mufaro Kanyangarara
• Phone: 8037777562
• Email: mufaro[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 380
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Hypothermia
• Neonatal Hypothermia

Intervention

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 36.5°C, signaling hypothermia and prompting caregiver to provide thermal care.
• 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.

Locations

Country	Name	City	State
Ghana	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

Sponsors (4)

Lead Sponsor	Collaborator
University of South Carolina	Centre for Learning and Childhood Development - Ghana, Ghana Health Services, Korle-Bu Teaching Hospital, Accra, Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothermia	Axilliary temperature <36.5 degrees Celsius assessed at 7 days	up to 28 days
Secondary	Weight gain	Change in weight in grams assessed at 7 days and 28 days	7 days and 28 days
Secondary	Kangaroo Mother Care	Proportion of babies who received KMC for at least 8 hours in the last 24 hours assessed at 7 days and 28 days	7 days and 28 days
Secondary	All cause mortality	Number of neonatal deaths	28 days
Secondary	Exclusive breastfeeding	Proportion of babies who were exclusively breastfed in the last 24 hours assessed at 7 days and 28 days	7 days and 28 days