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

Recruiting now · Not applicable

Conditions studied: Preterm Infant, Body Temperature

In brief

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).

Key facts

Study ID

NCT03919188

Run by

Centre Hospitalier Universitaire, Amiens

People needed

164

Starts

2022-01-01

Expected to finish

2025-12-01

Last updated by the study team

2025-05-29

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• newborn infant with polymalformative syndrome
• life threatening events or serious heart disease

Where it is running

• Amiens University Hospital — Amiens, Picardie, France (enrolling)

Full record on ClinicalTrials.gov

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