NCT00429000

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
788

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 30, 2007

Status Verified

January 1, 2007

First QC Date

January 26, 2007

Last Update Submit

January 29, 2007

Conditions

HypothermiaMorbidityMortality

Keywords

HypothermiaInfant mortalityInfant morbidityInterventionRandomisationLongitudinal research.Low-income country

Outcome Measures

Primary Outcomes (1)

  • o The prevalence of HT in each group

Secondary Outcomes (5)

  • 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

Interventions

thermospotDEVICE

Eligibility Criteria

AgeUp to 6 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project

Bissau, Bissau Region, 1004 codex, Guinea-Bissau

Location

MeSH Terms

Conditions

HypothermiaInfant Death

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsDeathPathologic Processes

Study Officials

  • Peter Aaby, DMSc

    Bandim Health Project

    PRINCIPAL INVESTIGATOR

  • Morten Sodemann, PhD, MD

    Bandim Health Project

    STUDY DIRECTOR

Central Study Contacts

Helene W Hvidman, MS

CONTACT

helenehvidman@studmed.ku.dk

Morten Sodemann, PhD, MD

CONTACT

mortenso@dadlnet.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 30, 2007

Study Start

January 1, 2007

Study Completion

October 1, 2007

Last Updated

January 30, 2007

Record last verified: 2007-01

Locations

GU(1)