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

NCT00429000 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 788

Last updated 2007-01-30

No results posted yet for this 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.

Conditions

  • Hypothermia
  • Morbidity
  • Mortality

Interventions

DEVICE

thermospot

Sponsors & Collaborators

  • Lundbeck Foundation

    collaborator OTHER

  • Augustinus Fonden

    collaborator OTHER

  • Danida Travel Grant,

    collaborator UNKNOWN

  • Dir E Danielsen og Hustrus Fond,

    collaborator UNKNOWN

  • Jakob og Olga Madsens Fond

    collaborator UNKNOWN

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Peter Aaby, DMSc · Bandim Health Project

  • Morten Sodemann, PhD, MD · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Completion
2007-10-31

Countries

  • Guinea-Bissau

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00429000 on ClinicalTrials.gov