Perinatal Hypothermia, Risk Factors and Long-Term Consequences in Guinea-Bissau, Westafrica
Primary Purpose
Hypothermia, Morbidity, Mortality
Status
Unknown status
Phase
Not Applicable
Locations
Guinea-Bissau
Study Type
Interventional
Intervention
thermospot
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia focused on measuring Hypothermia, Infant mortality, Infant morbidity, Intervention, Randomisation, Longitudinal research., Low-income country
Eligibility Criteria
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:
- 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.
Sites / Locations
- Bandim Health Project
Outcomes
Primary Outcome Measures
o The prevalence of HT in each group
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00429000
First Posted
January 26, 2007
Last Updated
January 29, 2007
Sponsor
Bandim Health Project
Collaborators
Lundbeck Foundation, Augustinus Fonden, Danida Travel Grant,, Dir E Danielsen og Hustrus Fond,, Jakob og Olga Madsens Fond
1. Study Identification
Unique Protocol Identification Number
NCT00429000
Brief Title
Perinatal Hypothermia, Risk Factors and Long-Term Consequences in Guinea-Bissau, Westafrica
Official Title
Reducing the Prevalence of Hypothermia Among Newborns by Means of Continuous Temperature Monitoring Using Thermospot.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bandim Health Project
Collaborators
Lundbeck Foundation, Augustinus Fonden, Danida Travel Grant,, Dir E Danielsen og Hustrus Fond,, Jakob og Olga Madsens Fond
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Morbidity, Mortality
Keywords
Hypothermia, Infant mortality, Infant morbidity, Intervention, Randomisation, Longitudinal research., Low-income country
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
788 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
thermospot
Primary Outcome Measure Information:
Title
o The prevalence of HT in each group
Secondary Outcome Measure Information:
Title
o Morbidity
Title
o Mortality
Title
o The incidence of infectious diseases
Title
o The prevalence of an adequate response to routine childhood vaccinations
Title
o Frequency of hospital admissions and consultations at local health care centres
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helene W Hvidman, MS
Email
helenehvidman@studmed.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Sodemann, PhD, MD
Email
mortenso@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Aaby, DMSc
Organizational Affiliation
Bandim Health Project
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Morten Sodemann, PhD, MD
Organizational Affiliation
Bandim Health Project
Official's Role
Study Director
Facility Information:
Facility Name
Bandim Health Project
City
Bissau
ZIP/Postal Code
1004 codex
Country
Guinea-Bissau
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Aaby, DMs
Email
p.aaby@bandim.org
First Name & Middle Initial & Last Name & Degree
Christina Rasmussen
Email
crn@ssi.dk
First Name & Middle Initial & Last Name & Degree
Helene W Hvidman, MS
12. IPD Sharing Statement
Learn more about this trial
Perinatal Hypothermia, Risk Factors and Long-Term Consequences in Guinea-Bissau, Westafrica
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