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

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ClinicalTrials.gov Identifier: NCT03648606
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Thermoregulation 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).

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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 .
Actual Study Start Date : June 4, 2010
Actual Primary Completion Date : January 25, 2017
Actual Study Completion Date : January 25, 2017

Intervention Details:
  • 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.



Primary Outcome Measures :
  1. Mesure of the Thermal confort of preterm infants less than 32 weeks [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648606


Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Pierre Tourneux, MD, PhD CHU AMIENS

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03648606    
Other Study ID Numbers: PI10-PR-TOURNEUX-1
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
infant
thermoregulation
wakefulness episode
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications