Clinical Trial: Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life
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 Summary:
Sponsor: Centre Hospitalier Universitaire, Amiens
Current Primary Outcome: Lowest abdominal skin temperature [ Time Frame: 20 minutes ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The nadir for peripheral skin temperature [ Time Frame: 20 minutes ]
- Pulse rate [ Time Frame: 20 minutes ]
- Morbidity [ Time Frame: 7 days ]
- mortality [ Time Frame: 7 days ]
- respiratory rate [ Time Frame: 20 minutes ]
- Blood pressure [ Time Frame: 20 minutes ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire, Amiens
Dates:
Date Received: June 6, 2016
Date Started: June 2009
Date Completion:
Last Updated: June 16, 2016
Last Verified: June 2016
