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

Completed

• Conditions: Hypothermia

• Registration Number: NCT02803606
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lowest abdominal skin temperature	20 minutes

Secondary Outcome Measures

Name	Time	Method
The nadir for peripheral skin temperature	20 minutes
Morbidity	7 days
Pulse rate	20 minutes
respiratory rate	20 minutes
Blood pressure	20 minutes
mortality	7 days

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France