Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429000
Status:
UNKNOWN
Last Update Posted:
2007-01-30
First Post:
2007-01-26
Brief Title:
Perinatal Hypothermia Risk Factors and Long-Term Consequences in Guinea-Bissau Westafrica
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
Reducing the Prevalence of Hypothermia Among Newborns by Means of Continuous Temperature Monitoring Using Thermospot
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 345C
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 3000 births in Guinea-Bissau we found 8 with HT 345C 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 345C
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 355C 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
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 355C 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None