Clinical trial NCT03648606: Management and Thermal Comfort of Premature Infants Under 32 Weeks
Official title: Improvement of the Early Management and Thermal Comfort of Premature Infants Under 32 Weeks of Amenorrhea Placed in a Closed Incubator: Comparison of the Use of the Incubator in Conventional "Air" vs. "Cutaneous" Regulation Mode .
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thermoregulation
Keywords: infant
thermoregulation
wakefulness episode
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 29
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premature infants less than 32 weeks of amenorrhea admitted to birth in the Neonatal Medicine Unit will be included after obtaining written parental consent. Data will be collected during the first 10 days of life of the preterm infant.

Brief summary: Sleep propensity was assessed in terms of the duration of a spontaneous episode of wakefulness (W). Skin temperatures at six body sites (the abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates (postmenstrual age: 209 9 days). Te investigators then determined whether the duration of the W episode depended upon the local skin temperatures measured at the start, during and end of the episode.

Detailed description: Although sleep is of paramount importance for preterm neonates, care of the latter in a neonatal intensive care unit does not favour sleep. Given that several studies in adults have described a 'vegetative preparedness to sleep' (in which distal skin vasodilation before lights-out promotes rapid sleep onset), the investigators looked at whether or not this process operates in preterm neonates. Sleep propensity was assessed in terms of the duration of a spontaneous episode of wakefulness (W). Skin temperatures at six body sites (the abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates (postmenstrual age: 209 9 days).

Eligibility criteria: Inclusion Criteria:

* premature newborns 25 to 32 weeks of amenorrhea;
* arrival in the Neonatal Medicine Unit \<12 hours of life;
* need for management in a closed incubator;
* availability of an incubator equipped with communication card.

Exclusion Criteria:

* premature newborns\> 32 weeks of amenorrhea;
* arrival in the Neonatal Medicine unit after 12 hours of life;
* presence of malformation syndrome or serious heart disease;
* pathology requiring management within the first 10 days of life;
* Apgar score \<5 at 10 minutes of life;
* need for initial management in an open incubator;
* unavailability of an incubator equipped with a communication card

Primary outcomes:
measure: Mesure of the Thermal confort of preterm infants less than 32 weeks
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Pierre Tourneux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: