Body Temperature, Preterm Infant
Conditions
Keywords
preterm neonates, incubator management, body temperature, relative air humidity, thermoneutrality
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).
Interventions
PROCEDUREair 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)
PROCEDUREskin 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).
Sponsors
University Hospital, Rouen
University Hospital, Caen
University Hospital, Lille
Centre Hospitalier Arras
Centre Hospitalier de Montreuil
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | until day 10 of life | Change in body weight between birth and day 10 of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort of the preterm infant | until day 10 of life | Comfort of the preterm infant will be estimated by using the newborn infant physical examination (NIPE) |
| thermal stress occurence | until day 10 of life | Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge |
| humidity challenge using TEWL | until day 10 of life | TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss |
| neonatal morbidity occurence | until age corresponding to 40 weeks of amenorrhea | neonatal morbidities are infectious rate, necrotizing enterocolitis (NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary dysplasia (BPD) and death |
| length of hospitalization stay | until age corresponding to 40 weeks of amenorrhea or end of hospitalization | length of hospitalization stay (number of days of hospitalization) |
Countries
France
Contacts
Primary ContactPierre Tourneux, Pr
Backup ContactMomar Diouf, Dr
Outcome results
None listed