Management and Thermal Comfort of Premature Infants Under 32 Weeks

Completed

• Conditions: Thermoregulation

• Registration Number: NCT03648606
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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).

Study Timeline

• Study Start: 2010-06-04
• Primary Completion: 2017-01-25
• Study Completion: 2017-01-25
• Status Verified: 2018-08
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mesure of the Thermal confort of preterm infants less than 32 weeks	10 days	The 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.