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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypothermia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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hypothermia

Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit

No interventions assigned to this group

Eligibility Criteria

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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® "

Minimum Eligible Age

25 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No