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Management and Thermal Comfort of Premature Infants Under 32 Weeks

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 .

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03648606
Acronym
CTNNP
Enrollment
29
Registered
2018-08-27
Start date
2010-06-04
Completion date
2017-01-25
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thermoregulation

Keywords

infant, thermoregulation, wakefulness episode

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).

Interventions

OTHERmesure of skin temperature

The infants are placed in a closed incubator to study the variability of the heart and respiratory frequencies according to the regulation of the incubator and to quantify the time spent outside. Data will be collected during the first 10 days of life of the preterm infant. 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). The 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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 10 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mesure of the Thermal confort of preterm infants less than 32 weeks10 daysThe objective of this study is to evaluate the thermal confort (variability of the heart and respiratory frequencies) of preterm infant placed in a clmosed incubator to reduce the thermal stress of the very premature newborn (\< 32 weeks of amenorrhea) during the first 10 days of life.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPierre Tourneux, PU-PH

CHU Amiens-Picardie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026