Amiens University Hospital
Amiens, Picardie, 80054, France
Location status: Recruiting
NCT Number: NCT03919188
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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All sexes
Interventional
Not applicable
Amiens, Picardie, 80054, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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).
Time frame: until day 10 of life
Change in body weight between birth and day 10 of life
Time frame: until day 10 of life
Comfort of the preterm infant will be estimated by using the newborn infant physical examination (NIPE)
Time frame: until day 10 of life
Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge
Time frame: until day 10 of life
TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss
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
Time frame: until age corresponding to 40 weeks of amenorrhea or end of hospitalization
length of hospitalization stay (number of days of hospitalization)
Contact information is provided by the study sponsor or research team.
Momar Diouf, Dr
CONTACT
Pierre Tourneux, Pr
CONTACT
Centre Hospitalier Universitaire, Amiens
Other
Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity
Acronym: ThermoKPreterm
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