CClinicalTrials.gg
Status unknownNCT00429000Updated Jan 30, 2007

Perinatal Hypothermia, Risk Factors and Long-Term Consequences in Guinea-Bissau, Westafrica

An interventional study of thermospot in Hypothermia, Morbidity and Mortality, sponsored by Bandim Health Project. Status unknown at 1 site in Guinea-Bissau. Open to participants aged Up to 6 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-01-30.

Sponsored by Bandim Health Project · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
788
Allocation
Randomized
Ages
Up to 6 Hours
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hypothermia
  • Morbidity
  • Mortality

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Keywords

  • Hypothermia
  • Infant mortality
  • Infant morbidity
  • Intervention
  • Randomisation
  • Longitudinal research.
  • Low-income country
03

In context

Hypothermia

499 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

This study's enrollment of 788 is above the median of 80 across 351 interventional studies indexed under Hypothermia.

Browse Hypothermia studies →

Lead sponsor

Bandim Health Project is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Hours
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
788 participants

Interventions

  • Devicethermospot
06

What researchers measure

Primary outcomes

  1. o The prevalence of HT in each group

Secondary outcomes

  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

07

Study locations

1 site
  • Bandim Health Project
    Bissau, 1004 codex, Guinea-Bissau
    • Peter Aaby, DMs · Contact · p.aaby@bandim.org
    • Christina Rasmussen · Contact · crn@ssi.dk
    • Helene W Hvidman, MS · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00429000
Lead sponsor
Bandim Health Project
Collaborators
Lundbeck Foundation, Augustinus Fonden, Danida Travel Grant,, Dir E Danielsen og Hustrus Fond,, Jakob og Olga Madsens Fond
First posted
Jan 30, 2007
Start date
Jan 2007
Completion
Oct 2007
Last update
Jan 30, 2007

Study contacts

Helene W Hvidman, MS
Contact
helenehvidman@studmed.ku.dk
Morten Sodemann, PhD, MD
Contact
mortenso@dadlnet.dk
Peter Aaby, DMSc
principal investigator · Bandim Health Project
Morten Sodemann, PhD, MD
study director · Bandim Health Project
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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