Clinical trial NCT04364204: Hypothermia Prevention in Low Birthweight and Preterm Infants
Official title: Hypothermia Prevention in Low Birthweight and Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Hypothermia
Keywords: newborn
low birthweight
kangaroo mother care
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Centre for Learning and Childhood Development - Ghana
name: Ghana Health Services
name: Korle-Bu Teaching Hospital, Accra, Ghana
First posted: 2020-04-28
Enrollment: 380
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Hypothermia
timeFrame: up to 28 days
Secondary outcomes:
measure: Weight gain
timeFrame: 7 days and 28 days
measure: Kangaroo Mother Care
timeFrame: 7 days and 28 days
measure: All cause mortality
timeFrame: 28 days
measure: Exclusive breastfeeding
timeFrame: 7 days and 28 days
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Achimota General Hospital
city: Accra
country: Ghana
facility: Greater Accra Regional Hospital
city: Accra
country: Ghana
facility: Korle-Bu Teaching Hospital
city: Accra
country: Ghana
facility: Princess Marie Luis Children's Hospital
city: Cape Coast
country: Ghana
facility: Central Regional Hospital
city: Koforidua
country: Ghana
facility: Eastern Regional Hospital
Study officials:
affiliation: University of South Carolina
name: Mufaro Kanyangarara
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Learning and Childhood Development - Ghana
name: Prince Owusu
role: PRINCIPAL_INVESTIGATOR
References: