Management and Thermal Comfort of Premature Infants Under 32 Weeks

Thermoregulation Clinical Trial

— CTNNP  

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 .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648606
• Other study ID #: PI10-PR-TOURNEUX-1
• Status: Completed
• Start date: June 4, 2010
• Est. completion date: January 25, 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 25, 2017
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 10 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Thermoregulation

Intervention

Other:
• mesure 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mesure of the Thermal confort of preterm infants less than 32 weeks	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.	10 days