HypothermiaNCT00429000
Perinatal Hypothermia, Risk Factors and Long-Term Consequences in Guinea-Bissau, Westafrica
A study testing thermospot in people with Hypothermia and Morbidity, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
Low body temperature (hypothermia (HT)) at birth contributes to infant mortality in low-income countries. A study from Guinéa-Bissau indicates that HT results in an increased mortality rate, which persist at least two months after birth. Read more about this study
- Who is it for?
- Ages Up to 6 hoursHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Morbidity, Mortality
- What is being tested?
- thermospot
- Type of treatment
- Medical device
- How many people
- 788 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Jan 2007to Oct 2007
- 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 6 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children born at the Maternity ward of the National Simão Mendes hospital in Bissau with a birth weight above 2500g resident within with a predefined geographic area.
Who cannot join
- Late abortions
- Stillbirths
- Birth weight below 2500g
- Residence within the study area of the Bandim Health Project, as these children are enrolled in other randomised trails.
Trial locations and contacts
1 site in 1 country.
Helene W Hvidman, MS contact
Morten Sodemann, PhD, MD contact
Guinea-Bissau1 site
Bandim Health Project
Bissau, Bissau Region, 1004 codex
Peter Aaby, DMs, p.aaby@bandim.org
Christina Rasmussen, crn@ssi.dk
About this study
Official title: Reducing the Prevalence of Hypothermia Among Newborns by Means of Continuous Temperature Monitoring Using Thermospot.
Low body temperature (hypothermia (HT)) at birth contributes to infant mortality in low-income countries. A study from Guinéa-Bissau indicates that HT results in an increased mortality rate, which persist at least two months after birth. Therefore interventions that reduce the prevalence of HT might have a significant effect on infant mortality. The purpose of the proposed study is to identify risk factors for HT in an in-hospital setting in Guinea-Bissau and to investigate whether continuous temperature-monitoring enabling early detection of HT and treatment can prevent HT <34,5°C.
Read the detailed description
Hypothermia (HT) has been recognized as a significant contributor to perinatal morbidity and mortality. Newborns are at risk of developing HT, as their temperature regulation is limited and HT remains a problem in developing countries with poor health care resources, as sub-optimal care for newborns increases the risk of HT. In a longitudinal combined hospital and community study of nearly 3,000 births in Guinea-Bissau we found 8% with HT <34,5°C and that HT within 12 hours of birth is associated with an excess mortality that exists beyond the neonatal period and probably exerts its effects to at least two months of age. The study indicates that the contribution of HT on infant mortality might be higher than presently estimated. In order to meet the fourth goal of The Millennium Developmental Goals, which commits the international community to reducing the mortality in children aged younger then 5 years by two-thirds between 1990 and 2015, a reduction in neonatal mortality rate is essential. Reducing the prevalence of HT might contribute to this. The purpose of the proposed study is to identify risk factors for HT in an in-hospital setting in Guinea-Bissau, and to investigate whether continuous temperature-monitoring enabling early detection of HT and treatment can prevent HT <34,5°C.
The randomised clinical trail will be carried out at the Maternity ward of the National Simão Mendes hospital in Bissau, Guinea Bissau, West Africa. Newborns will be randomised to either standard temperature measurement within the first 12 hours of birth or to continuous temperature monitoring by means of a thermospot, a liquid crystal thermometer shaped as a small small smiley, which changes colour from a green smiling face to black, when the temperature falls below 35.5°C enabling early detection of HT. As it is well known that drying, wrapping and physical contact can improve thermal balance of the newborn, a general intervention aimed at all newborns to prevent HT including changes in existing routines during delivery and immediate perinatal care according to the WHO guidelines will be introduced. All children will benefit from this general intervention. Prior to the intervention study a course in basic neonatology will be held in order to raise awareness of hypothermia among the staff at the maternity. A project assistant will visit all included children in order to follow up on morbidity and mortality.
- Conditions
- Hypothermia, Morbidity, Mortality
- Being tested
- thermospot
- Keywords
- Hypothermia, Infant mortality, Infant morbidity, Intervention, Randomisation, Longitudinal research., Low-income country
- Medical subject headings
- Hypothermia, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermospotDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
o The prevalence of HT in each group
Secondary outcomes (5)
o Morbidity
o Mortality
o The incidence of infectious diseases
o The prevalence of an adequate response to routine childhood vaccinations
o Frequency of hospital admissions and consultations at local health care centres
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startJan 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- 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
- 788 participants
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Augustinus Fonden, Danida Travel Grant,, Dir E Danielsen og Hustrus Fond,, Jakob og Olga Madsens Fond
- Investigators
- Peter Aaby, DMSc, Principal investigator, Bandim Health ProjectMorten Sodemann, PhD, MD, Study director, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429000
- Sponsor's protocol ID
- 2007HT
- Status last verified
- Jan 2007
- First submitted
- 26 Jan 2007
- Last updated
- 30 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Prevalence of Hypothermia Among Newborns by Means of Continuous Temperature Monitoring Using Thermospot.
- ClinicalTrials.gov ID
- NCT00429000
- Acronym / sponsor ID
- 2007HT
- Conditions
- Hypothermia, Morbidity, Mortality
- Keywords
- Hypothermia, Infant mortality, Infant morbidity, Intervention, Randomisation, Longitudinal research., Low-income country
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 788 participants
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Augustinus Fonden, Danida Travel Grant,, Dir E Danielsen og Hustrus Fond,, Jakob og Olga Madsens Fond
- Study start
- Jan 2007
- Study completion
- Oct 2007
- First posted
- 30 Jan 2007 (estimated)
- 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.
Low body temperature (hypothermia (HT)) at birth contributes to infant mortality in low-income countries. A study from Guinéa-Bissau indicates that HT results in an increased mortality rate, which persist at least two months after birth. Therefore interventions that reduce the prevalence of HT might have a significant effect on infant mortality. The purpose of the proposed study is to identify risk factors for HT in an in-hospital setting in Guinea-Bissau and to investigate whether continuous temperature-monitoring enabling early detection of HT and treatment can prevent HT <34,5°C.
Detailed description
Hypothermia (HT) has been recognized as a significant contributor to perinatal morbidity and mortality. Newborns are at risk of developing HT, as their temperature regulation is limited and HT remains a problem in developing countries with poor health care resources, as sub-optimal care for newborns increases the risk of HT. In a longitudinal combined hospital and community study of nearly 3,000 births in Guinea-Bissau we found 8% with HT <34,5°C and that HT within 12 hours of birth is associated with an excess mortality that exists beyond the neonatal period and probably exerts its effects to at least two months of age. The study indicates that the contribution of HT on infant mortality might be higher than presently estimated. In order to meet the fourth goal of The Millennium Developmental Goals, which commits the international community to reducing the mortality in children aged younger then 5 years by two-thirds between 1990 and 2015, a reduction in neonatal mortality rate is essential. Reducing the prevalence of HT might contribute to this. The purpose of the proposed study is to identify risk factors for HT in an in-hospital setting in Guinea-Bissau, and to investigate whether continuous temperature-monitoring enabling early detection of HT and treatment can prevent HT <34,5°C.
The randomised clinical trail will be carried out at the Maternity ward of the National Simão Mendes hospital in Bissau, Guinea Bissau, West Africa. Newborns will be randomised to either standard temperature measurement within the first 12 hours of birth or to continuous temperature monitoring by means of a thermospot, a liquid crystal thermometer shaped as a small small smiley, which changes colour from a green smiling face to black, when the temperature falls below 35.5°C enabling early detection of HT. As it is well known that drying, wrapping and physical contact can improve thermal balance of the newborn, a general intervention aimed at all newborns to prevent HT including changes in existing routines during delivery and immediate perinatal care according to the WHO guidelines will be introduced. All children will benefit from this general intervention. Prior to the intervention study a course in basic neonatology will be held in order to raise awareness of hypothermia among the staff at the maternity. A project assistant will visit all included children in order to follow up on morbidity and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children born at the Maternity ward of the National Simão Mendes hospital in Bissau with a birth weight above 2500g resident within with a predefined geographic area.
Key exclusion criteria (4 listed)
- Late abortions
- Stillbirths
- Birth weight below 2500g
- Residence within the study area of the Bandim Health Project, as these children are enrolled in other randomised trails.
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 |
|---|---|---|
| thermospot | Device | – |
Primary outcome
o The prevalence of HT in each group
5 secondary outcomes
o Morbidity
o Mortality
o The incidence of infectious diseases
o The prevalence of an adequate response to routine childhood vaccinations
o Frequency of hospital admissions and consultations at local health care centres
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2007.
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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.
Helene W Hvidman, MS contact
Morten Sodemann, PhD, MD contact
Peter Aaby, DMSc principal investigator
Bandim Health Project
Morten Sodemann, PhD, MD study director
Bandim Health Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermospot in people with Hypothermia and Morbidity, run by Bandim Health Project at 1 site in Guinea-Bissau.
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 1 inclusion and 4 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 30 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. 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 Helene W Hvidman, MS (helenehvidman@studmed.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
o The prevalence of HT in each group. 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 30 Jan 2007; AzTrials last refreshed its copy on 7 Nov 2026.