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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

helenehvidman@studmed.ku.dk

Morten Sodemann, PhD, MD contact

mortenso@dadlnet.dk

Guinea-Bissau1 site
  • Bandim Health Project

    Bissau, Bissau Region, 1004 codex

    Peter Aaby, DMs, p.aaby@bandim.org

    Christina Rasmussen, crn@ssi.dk

Other trials in Guinea-Bissau

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.

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.

  1. o The prevalence of HT in each group

Secondary outcomes (5)
  1. o Morbidity

  2. o Mortality

  3. o The incidence of infectious diseases

  4. o The prevalence of an adequate response to routine childhood vaccinations

  5. 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.

  1. First posted30 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Study completionOct 2007

Resources

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
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

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.

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