Management and Thermal Comfort of Premature Infants Under 32 Weeks (CTNNP)

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 .

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.

Study Overview

• Status: Completed
• Conditions: Thermoregulation
• Intervention / Treatment: Other: mesure of skin temperature

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 Type: Observational
• Enrollment (Actual): 29

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Pierre Tourneux, MD, PhD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2010
• Primary Completion (Actual): January 25, 2017
• Study Completion (Actual): January 25, 2017

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: thermoregulation; infant; wakefulness episode
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PI10-PR-TOURNEUX-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No