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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

newborn infant with polymalformative syndrome

life threatening events or serious heart disease

Trial design

Treatments tested in this trial

  • air temperature control (ATC)
  • skin servocontrol (SSC)

Treatment groups

164 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Universitaire, Amiens

Lead sponsor

University Hospital, Rouen

Collaborator

University Hospital, Caen

Collaborator

University Hospital, Lille

Collaborator

Centre Hospitalier Arras

Collaborator

Centre Hospitalier de Montreuil

Collaborator