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NCT02803606 Clinical Trial

Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life

Hypothermia Clinical Trial

— PREMARISQ  

Official title:
Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02803606
Other study ID # AOL08-DR-TOURNEUX
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2009
Est. completion date June 2012

Study information
Verified date August 2018
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit will be included after informing the parents. Abdominal skin and peripheral (arm or leg) and incubator air temperatures and relative humidity will be obtained from data recorded by the incubator without using any additional transducer compared to standard care. Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization will also be recorded from routine monitoring. A case report form and a wide-angle video recording of the infant's room will allow description of the type of care, determine the duration of care and the impact on incubator function. Data will be recorded for the first 7 days of life of the preterm neonate.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 25 Weeks to 32 Weeks
Eligibility Inclusion Criteria:

- Preterm infants of 25-32 weeks of gestation

- Birth in one of the two maternity hospitals of Amiens agglomeration (CGO or clinic of Europe )

- Arrived in the Neonatal Medicine unit < 2 hours of life

- Necessitated a care in an incubator

Exclusion Criteria:

- Preterm infants > 32 weeks of gestation

- Birth outside the Amiens metropolitan area

- Arrived in the Neonatal Medicine unit after 2 hours of life

- Present a malformation syndrome or severe heart disease

- Pathology requiring support within the first 7 days of life

- Apgar score < 5 to 10 minutes of life

- Need for initial management in open incubator

- Unavailability of a type of incubator " Caleo® "

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lowest abdominal skin temperature 20 minutes
Secondary The nadir for peripheral skin temperature 20 minutes
Secondary Pulse rate 20 minutes
Secondary Morbidity 7 days
Secondary mortality 7 days
Secondary respiratory rate 20 minutes
Secondary Blood pressure 20 minutes
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