Neonatal HypothermiaNCT04364204
Hypothermia Prevention in Low Birthweight and Preterm Infants
A study testing Kangaroo Mother Care and BEMPU bracelet and Kangaroo Mother Care in people with Neonatal Hypothermia, run by University of South Carolina at 6 sites in Ghana.
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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal Hypothermia
- What is being tested?
- Kangaroo Mother Care and BEMPU bracelet and Kangaroo Mother Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 6 sitesGhana
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Ghana6 sites
Achimota General Hospital
Accra
Prince Owusu
Greater Accra Regional Hospital
Accra
Prince Owusu
Korle-Bu Teaching Hospital
Accra
Prince Owusu
Princess Marie Luis Children's Hospital
Accra
Prince Owusu
Central Regional Hospital
Cape Coast
Prince Owusu
Eastern Regional Hospital
Koforidua
Prince Owusu
About this study
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.
Read the 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
- Being tested
- Kangaroo Mother Care and BEMPU bracelet, Kangaroo Mother Care
- Keywords
- newborn, low birthweight, kangaroo mother care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother Care and BEMPU braceletOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo mother care with bracelet | Experimental | Not described Receives: Other: Kangaroo Mother Care and BEMPU bracelet |
| Kangaroo mother care | Active comparator | Not described Receives: Other: Kangaroo Mother Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothermia
Axilliary temperature <36.5 degrees Celsius assessed at 7 days
Measured: up to 28 days
Secondary outcomes (4)
Weight gain
Change in weight in grams assessed at 7 days and 28 days
Measured: 7 days and 28 days
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
Measured: 7 days and 28 days
All cause mortality
Number of neonatal deaths
Measured: 28 days
Exclusive breastfeeding
Proportion of babies who were exclusively breastfed in the last 24 hours assessed at 7 days and 28 days
Measured: 7 days and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypothermiaStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Learning and Childhood Development - Ghana, Ghana Health Services, Korle-Bu Teaching Hospital, Accra, Ghana
- Responsible party
- Principal investigator, Mufaro Kanyangarara, University of South Carolina
- Investigators
- Mufaro Kanyangarara, Principal investigator, University of South CarolinaPrince Owusu, Principal investigator, Centre for Learning and Childhood Development - Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364204
- Sponsor's protocol ID
- Pro00095600
- Status last verified
- Sep 2021
- First submitted
- 16 Mar 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermia Prevention in Low Birthweight and Preterm Infants
- ClinicalTrials.gov ID
- NCT04364204
- Acronym / sponsor ID
- Pro00095600
- Conditions
- Neonatal Hypothermia
- Keywords
- newborn, low birthweight, kangaroo mother care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Centre for Learning and Childhood Development - Ghana, Ghana Health Services, Korle-Bu Teaching Hospital, Accra, Ghana
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kangaroo mother care with bracelet | Experimental | Other: Kangaroo Mother Care and BEMPU bracelet |
| Kangaroo mother care | Active comparator | Other: Kangaroo Mother Care |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo Mother Care and BEMPU braceletKangaroo 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 with bracelet |
| Kangaroo Mother CareKangaroo 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. | Other | Kangaroo mother care |
Primary outcome
Hypothermia
Time frame: up to 28 days
Axilliary temperature <36.5 degrees Celsius assessed at 7 days
4 secondary outcomes
Weight gain
Time frame: 7 days and 28 days
Kangaroo Mother Care
Time frame: 7 days and 28 days
All cause mortality
Time frame: 28 days
Exclusive breastfeeding
Time frame: 7 days and 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No
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Hypoxic-Ischemic Encephalopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mufaro Kanyangarara principal investigator
University of South Carolina
Prince Owusu principal investigator
Centre for Learning and Childhood Development - Ghana
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Mother Care and BEMPU bracelet and Kangaroo Mother Care in people with Neonatal Hypothermia, run by University of South Carolina at 6 sites in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mufaro Kanyangarara (8037777562, mufaro@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothermia (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.