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

Study Overview
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Brief Summary
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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).

Official Title
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Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity

Conditions
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Preterm Infant, Body Temperature

Intervention / Treatment
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* Procedure: air temperature control (ATC)
* Procedure: skin servocontrol (SSC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: air temperature control (ATC)<br>Incubator control using air temperature control (ATC) method | Procedure: air temperature control (ATC)<br>* 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)<br>|
| Active Comparator: skin servocontrol (SSC)<br>Incubator control using skin servocontrol method | Procedure: skin servocontrol (SSC)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Change in body weight between birth and day 10 of life | until day 10 of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of the preterm infant | Comfort of the preterm infant will be estimated by using the newborn infant physical examination (NIPE) | until day 10 of life | 
| thermal stress occurence | Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge | until day 10 of life | 
| humidity challenge using TEWL | TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss | until day 10 of life | 
| neonatal morbidity occurence | neonatal morbidities are infectious rate, necrotizing enterocolitis (NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary dysplasia (BPD) and death | until age corresponding to 40 weeks of amenorrhea | 
| length of hospitalization stay | length of hospitalization stay (number of days of hospitalization) | until age corresponding to 40 weeks of amenorrhea or end of hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm neonates, incubator management, body temperature, relative air humidity, thermoneutrality