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Completed

NCT Number: NCT02803606

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

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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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 week–32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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® "

Treatment and study plan

Primary outcomes

  1. Lowest abdominal skin temperature

    Time frame: 20 minutes

Secondary outcomes

  1. The nadir for peripheral skin temperature

    Time frame: 20 minutes

  2. Pulse rate

    Time frame: 20 minutes

  3. Morbidity

    Time frame: 7 days

  4. mortality

    Time frame: 7 days

  5. respiratory rate

    Time frame: 20 minutes

  6. Blood pressure

    Time frame: 20 minutes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PREMARISQ

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2016
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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