Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life
PREMARISQ
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 6, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedAugust 10, 2018
August 1, 2018
3 years
June 6, 2016
August 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lowest abdominal skin temperature
20 minutes
Secondary Outcomes (6)
The nadir for peripheral skin temperature
20 minutes
Pulse rate
20 minutes
Morbidity
7 days
mortality
7 days
respiratory rate
20 minutes
- +1 more secondary outcomes
Study Arms (1)
hypothermia
Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit
Eligibility Criteria
Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit
You may qualify if:
- 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
You may not qualify if:
- 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® "
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre TOURNEUX, MD,PhD
CHU Amiens
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2016
First Posted
June 17, 2016
Study Start
June 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
August 10, 2018
Record last verified: 2018-08