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Preterm Infant in Incubators: Automated Thermal Control Improved Weight Growth and Decreased Morbidity (ThermoKPreterm)

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ClinicalTrials.gov Identifier: NCT03919188
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
University Hospital, Rouen
University Hospital, Caen
University Hospital, Lille
Centre Hospitalier VALENCIENNES
Centre Hospitalier Arras
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. That can be decreased by reducing body heat losses to the environment. A software to assess the optimal thermal neutral range taking into account all the neonate's heat losses in closed incubators has been designed by a multidisciplinary research team. The principle is to calculate the body heat loss (BHL) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce BHL to zero. This software is now available for clinical practice in the INOTHERM incubator (Mediprema, France). This study aims to compare the energy costs of providing incubated preterm infants born before 32 weeks of gestation with homeotherm using either BHL air control (BHL) or air temperature control (ATC) or skin servocontrol (SSC).

Condition or disease Intervention/treatment Phase
Preterm Infant Body Temperature Procedure: computer adjusted air temperature control to minimize Body Heat Loss (BHL) compared to current Procedure: air temperature control (ATC) Procedure: skin servocontrol (SSC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preterm Infant in Incubators: Automated Thermal Control in Randomized Trial - Improved Weight Growth and Decreased Morbidity
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: body heat loss (BHL) air control
Incubator control using BHL air control method
Procedure: computer adjusted air temperature control to minimize Body Heat Loss (BHL) compared to current
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): First parameter : computer adjusted air temperature control to minimize Body Heat Loss (BHL) compared to current

Procedure: air temperature control (ATC)
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): second parameter : air temperature control (ATC)

Procedure: skin servocontrol (SSC)
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): Third parameter : skin servocontrol (SSC).

Active Comparator: air temperature control (ATC)
Incubator control using air temperature control (ATC) method
Procedure: computer adjusted air temperature control to minimize Body Heat Loss (BHL) compared to current
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): First parameter : computer adjusted air temperature control to minimize Body Heat Loss (BHL) compared to current

Procedure: air temperature control (ATC)
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): second parameter : air temperature control (ATC)

Procedure: skin servocontrol (SSC)
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): Third parameter : skin servocontrol (SSC).

Active Comparator: skin servocontrol (SSC)
Incubator control using skin servocontrol method
Procedure: computer adjusted air temperature control to minimize Body Heat Loss (BHL) compared to current
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): First parameter : computer adjusted air temperature control to minimize Body Heat Loss (BHL) compared to current

Procedure: air temperature control (ATC)
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): second parameter : air temperature control (ATC)

Procedure: skin servocontrol (SSC)
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): Third parameter : skin servocontrol (SSC).




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: until day 10 of life ]
    Change in body weight between birth and day 10 of life


Secondary Outcome Measures :
  1. Comfort of the preterm infant [ Time Frame: until day 10 of life ]
    Comfort of the preterm infant will be estimated by using the newborn infant physical examination (NIPE)

  2. thermal stress occurence [ Time Frame: until day 10 of life ]
    Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge

  3. humidity challenge using TEWL [ Time Frame: until day 10 of life ]
    TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss

  4. neonatal morbidity occurence [ Time Frame: until age corresponding to 40 weeks of amenorrhea ]
    neonatal morbidities are infectious rate, necrotizing enterocolitis (NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary dysplasia (BPD) and death

  5. length of hospitalization stay [ Time Frame: until age corresponding to 40 weeks of amenorrhea or end of hospitalization ]
    length of hospitalization stay (number of days of hospitalization)



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm infant born before 32 weeks of gestation
  • preterm infant included in the study before 12 hours of life
  • preterm infant nursed in an INOTHERM incubator
  • written informed consent from his parents

Exclusion Criteria:

  • newborn infant with polymalformative syndrome
  • life threatening events or serious heart disease

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): NCT03919188


Contacts
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Contact: Pierre Tourneux, Pr (33)322087604 tourneux.pierre@chu-amiens.fr
Contact: Momar Diouf, Dr (33)322088371 diouf.momar@chu-amiens.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
University Hospital, Rouen
University Hospital, Caen
University Hospital, Lille
Centre Hospitalier VALENCIENNES
Centre Hospitalier Arras
Investigators
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Principal Investigator: Thierry Blanc, MD CHU Rouen
Principal Investigator: Bernard Guillois, Pr CHU Caen
Principal Investigator: Laurent Storme, Pr CHRU Lille
Principal Investigator: fabrice Lapeyre, MD CH Valenciennes
Principal Investigator: Julien Ghesquière, MD CH Arras

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03919188     History of Changes
Other Study ID Numbers: PI2018_843_0056
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
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:
preterm neonates
incubator management
body temperature
relative air humidity
thermoneutrality

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications