Management and Thermal Comfort of Premature Infants Under 32 Weeks

NCT03648606 | Completed

• 1 other identifier: PI10-PR-TOURNEUX-1
• Study Type: observational
• Target: 29
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thermoregulation

Keywords

infant; thermoregulation; wakefulness episode

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

mesure of skin temperature OTHER

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.

Eligibility Criteria

• Age: 1 Day - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Officials

• Pierre Tourneux, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 27, 2018
• Study Start: June 4, 2010
• Primary Completion: January 25, 2017
• Study Completion: January 25, 2017
• Last Updated: May 17, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share