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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT02803606
Collaborator
(none)
30
Enrollment
1
Location
36
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    hypothermia

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

    Outcome Measures

    Primary Outcome Measures

    1. Lowest abdominal skin temperature [20 minutes]

    Secondary Outcome Measures

    1. The nadir for peripheral skin temperature [20 minutes]

    2. Pulse rate [20 minutes]

    3. Morbidity [7 days]

    4. mortality [7 days]

    5. respiratory rate [20 minutes]

    6. Blood pressure [20 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Weeks to 32 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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® "

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Amiens France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    • Principal Investigator: Pierre TOURNEUX, MD,PhD, CHU Amiens

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT02803606
    Other Study ID Numbers:
    • AOL08-DR-TOURNEUX
    First Posted:
    Jun 17, 2016
    Last Update Posted:
    Aug 10, 2018
    Last Verified:
    Aug 1, 2018
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    hypothermia
    routine care
    preterm neonates
    Additional relevant MeSH terms:
    Hypothermia

    Study Results

    No Results Posted as of Aug 10, 2018