Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body G
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
| Condition(s) | Preterm Infant, Body Temperature |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 st |
| Who can participate | 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 | 1 Day |
| Sex | All |
| Lead sponsor | Centre Hospitalier Universitaire, Amiens |
| Locations | Amiens, Picardie, France |
| Start date | 2022-01-01 |
| NCT ID | NCT03919188 |
| Official listing | https://clinicaltrials.gov/study/NCT03919188 |