Preterm InfantThermoKPretermNCT03919188
Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
A study of Preterm Infant and Body Temperature, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Preterm Infant, Body Temperature
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- newborn infant with polymalformative syndrome
- life threatening events or serious heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, Picardie, 80054
Pierre Tourneux, MD, +33 3 22 66 82 86, tourneux.pierre@chu-amiens.fr
About this study
Official title: Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity
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).
- Conditions
- Preterm Infant, Body Temperature
- Being tested
- air temperature control (ATC), skin servocontrol (SSC)
- Keywords
- preterm neonates, incubator management, body temperature, relative air humidity, thermoneutrality
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air temperature control (ATC)Procedure or surgery
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)
skin servocontrol (SSC)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| air temperature control (ATC) | Active comparator | Incubator control using air temperature control (ATC) method Receives: Procedure: air temperature control (ATC) |
| skin servocontrol (SSC) | Active comparator | Incubator control using skin servocontrol method Receives: Procedure: skin servocontrol (SSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Change in body weight between birth and day 10 of life
Measured: until day 10 of life
Secondary outcomes (5)
Comfort of the preterm infant
Comfort of the preterm infant will be estimated by using the newborn infant physical examination (NIPE)
Measured: until day 10 of life
thermal stress occurence
Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge
Measured: until day 10 of life
humidity challenge using TEWL
TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss
Measured: until day 10 of life
neonatal morbidity occurence
neonatal morbidities are infectious rate, necrotizing enterocolitis (NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary dysplasia (BPD) and death
Measured: until age corresponding to 40 weeks of amenorrhea
length of hospitalization stay
length of hospitalization stay (number of days of hospitalization)
Measured: until age corresponding to 40 weeks of amenorrhea or end of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Caen, University Hospital, Lille, Centre Hospitalier Arras, Centre Hospitalier de Montreuil
- Responsible party
- Sponsor
- Investigators
- Alexandre Cénéric, Dr, Principal investigator, University Hospital, CaenKévin Leduc, Dr, Principal investigator, CHRU LILLESophie Galène, MD, Principal investigator, CHU RouenGuillaume ESCOURROU, MD, Principal investigator, CHI André Grégoire - MontreuilJulien Ghesquière, MD, Principal investigator, CH Arras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919188
- Sponsor's protocol ID
- PI2018_843_0056
- Acronym
- ThermoKPreterm
- Status last verified
- May 2025
- First submitted
- 15 Apr 2019
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity
- ClinicalTrials.gov ID
- NCT03919188
- Acronym / sponsor ID
- ThermoKPreterm / PI2018_843_0056
- Conditions
- Preterm Infant, Body Temperature
- Keywords
- preterm neonates, incubator management, body temperature, relative air humidity, thermoneutrality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Caen, University Hospital, Lille, Centre Hospitalier Arras, Centre Hospitalier de Montreuil
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| air temperature control (ATC) | Active comparator | Procedure: air temperature control (ATC)Incubator control using air temperature control (ATC) method |
| skin servocontrol (SSC) | Active comparator | Procedure: skin servocontrol (SSC)Incubator control using skin servocontrol method |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- newborn infant with polymalformative syndrome
- life threatening events or serious heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | air temperature control (ATC) |
| 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). | Procedure or surgery | skin servocontrol (SSC) |
Primary outcome
Change in body weight
Time frame: until day 10 of life
Change in body weight between birth and day 10 of life
5 secondary outcomes
Comfort of the preterm infant
Time frame: until day 10 of life
thermal stress occurence
Time frame: until day 10 of life
humidity challenge using TEWL
Time frame: until day 10 of life
neonatal morbidity occurence
Time frame: until age corresponding to 40 weeks of amenorrhea
length of hospitalization stay
Time frame: until age corresponding to 40 weeks of amenorrhea or end of hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre Cénéric, Dr principal investigator
University Hospital, Caen
Kévin Leduc, Dr principal investigator
CHRU LILLE
Sophie Galène, MD principal investigator
CHU Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Preterm Infant and Body Temperature, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Tourneux, Pr ((33)322087604, tourneux.pierre@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: until day 10 of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.