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| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
| University Hospital, Caen | OTHER |
| University Hospital, Lille | OTHER |
| Centre Hospitalier Arras |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| air temperature control (ATC) | Active Comparator | Incubator control using air temperature control (ATC) method |
|
| skin servocontrol (SSC) | Active Comparator | Incubator control using skin servocontrol method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| air temperature control (ATC) | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Change in body weight between birth and day 10 of life | until day 10 of life |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Tourneux, Pr | Contact | (33)322087604 | tourneux.pierre@chu-amiens.fr | |
| Momar Diouf, Dr | Contact | (33)322088371 | diouf.momar@chu-amiens.fr |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre Cénéric, Dr | University Hospital, Caen | Principal Investigator |
| Kévin Leduc, Dr | CHRU LILLE | Principal Investigator |
| Sophie Galène, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens University Hospital | Recruiting | Amiens | Picardie | 80054 | France |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
| Centre Hospitalier de Montreuil | UNKNOWN |
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|
| skin servocontrol (SSC) | Procedure | 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). |
|
| 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 |
| CHU Rouen |
| Principal Investigator |
| Guillaume ESCOURROU, MD | CHI André Grégoire - Montreuil | Principal Investigator |
| Julien Ghesquière, MD | CH Arras | Principal Investigator |
| D000091642 | Urogenital Diseases |