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

NCT ID: NCT00429000

Last Updated: 2007-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 788 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-10-31

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.

Conditions

Hypothermia; Morbidity; Mortality

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

thermospot

Intervention Type: DEVICE

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.

• Maximum Eligible Age: 6 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lundbeck Foundation

OTHER

Sponsor Role: collaborator

Augustinus Fonden

OTHER

Sponsor Role: collaborator

Danida Travel Grant,

UNKNOWN

Sponsor Role: collaborator

Dir E Danielsen og Hustrus Fond,

UNKNOWN

Sponsor Role: collaborator

Jakob og Olga Madsens Fond

UNKNOWN

Sponsor Role: collaborator

Bandim Health Project

OTHER

Sponsor Role: lead

Principal Investigators

Peter Aaby, DMSc

Role: PRINCIPAL_INVESTIGATOR

Bandim Health Project

Morten Sodemann, PhD, MD

Role: STUDY_DIRECTOR

Bandim Health Project

Locations

Bandim Health Project

Bissau, Bissau Region, Guinea-Bissau

Countries

Guinea-Bissau

Central Contacts

Helene W Hvidman, MS

Role: CONTACT

Email: helenehvidman@studmed.ku.dk

Morten Sodemann, PhD, MD

Role: CONTACT

Email: mortenso@dadlnet.dk

Facility Contacts

Peter Aaby, DMs

Role: primary

Christina Rasmussen

Role: backup

Other Identifiers

2007HT

Identifier Type: -

Identifier Source: org_study_id