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Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity (ThermoKPreterm)

Primary Purpose

Preterm Infant, Body Temperature

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
air temperature control (ATC)
skin servocontrol (SSC)
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Infant focused on measuring preterm neonates, incubator management, body temperature, relative air humidity, thermoneutrality

Eligibility Criteria

undefined - 1 Day (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preterm infant born between 25+0 and 32+0 weeks of gestation
  • preterm infant included in the study before 24 +/- 12 hours of life
  • preterm infant nursed in a closed incubator
  • written informed consent from his parents

Exclusion Criteria:

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

Sites / Locations

  • Amiens University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

air temperature control (ATC)

skin servocontrol (SSC)

Arm Description

Incubator control using air temperature control (ATC) method

Incubator control using skin servocontrol method

Outcomes

Primary Outcome Measures

Change in body weight
Change in body weight between birth and day 10 of life

Secondary Outcome Measures

Comfort of the preterm infant
Comfort of the preterm infant will be estimated by using the newborn infant physical examination (NIPE)
thermal stress occurence
Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge
humidity challenge using TEWL
TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss
neonatal morbidity occurence
neonatal morbidities are infectious rate, necrotizing enterocolitis (NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary dysplasia (BPD) and death
length of hospitalization stay
length of hospitalization stay (number of days of hospitalization)

Full Information

First Posted
April 15, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
University Hospital, Rouen, University Hospital, Caen, University Hospital, Lille, Centre Hospitalier Arras, Centre Hospitalier de Montreuil
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1. Study Identification

Unique Protocol Identification Number
NCT03919188
Brief Title
Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
Acronym
ThermoKPreterm
Official Title
Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
University Hospital, Rouen, University Hospital, Caen, University Hospital, Lille, Centre Hospitalier Arras, Centre Hospitalier de Montreuil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment. The investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. The secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality. A software is used 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 has been validated in a previous pilot study (Degorre et al. 2015). This study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (ATC) or skin servocontrol (SSC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Body Temperature
Keywords
preterm neonates, incubator management, body temperature, relative air humidity, thermoneutrality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
air temperature control (ATC)
Arm Type
Active Comparator
Arm Description
Incubator control using air temperature control (ATC) method
Arm Title
skin servocontrol (SSC)
Arm Type
Active Comparator
Arm Description
Incubator control using skin servocontrol method
Intervention Type
Procedure
Intervention Name(s)
air temperature control (ATC)
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
skin servocontrol (SSC)
Intervention Description
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 Measure Information:
Title
Change in body weight
Description
Change in body weight between birth and day 10 of life
Time Frame
until day 10 of life
Secondary Outcome Measure Information:
Title
Comfort of the preterm infant
Description
Comfort of the preterm infant will be estimated by using the newborn infant physical examination (NIPE)
Time Frame
until day 10 of life
Title
thermal stress occurence
Description
Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge
Time Frame
until day 10 of life
Title
humidity challenge using TEWL
Description
TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss
Time Frame
until day 10 of life
Title
neonatal morbidity occurence
Description
neonatal morbidities are infectious rate, necrotizing enterocolitis (NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary dysplasia (BPD) and death
Time Frame
until age corresponding to 40 weeks of amenorrhea
Title
length of hospitalization stay
Description
length of hospitalization stay (number of days of hospitalization)
Time Frame
until age corresponding to 40 weeks of amenorrhea or end of hospitalization

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: preterm infant born between 25+0 and 32+0 weeks of gestation preterm infant included in the study before 24 +/- 12 hours of life preterm infant nursed in a closed incubator written informed consent from his parents Exclusion Criteria: newborn infant with polymalformative syndrome life threatening events or serious heart disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Tourneux, Pr
Phone
(33)322087604
Email
tourneux.pierre@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Momar Diouf, Dr
Phone
(33)322088371
Email
diouf.momar@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Cénéric, Dr
Organizational Affiliation
CHU Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kévin Leduc, Dr
Organizational Affiliation
CHRU Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sophie Galène, MD
Organizational Affiliation
CHU Rouen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillaume ESCOURROU, MD
Organizational Affiliation
CHI André Grégoire - Montreuil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julien Ghesquière, MD
Organizational Affiliation
CH Arras
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Tourneux, MD
Phone
+33 3 22 66 82 86
Email
tourneux.pierre@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity

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