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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Preterm Infant; Body Temperature

Treatments: Procedure: skin servocontrol (SSC); Procedure: air temperature control (ATC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03919188

PI2018_843_0056

Details and patient eligibility

About

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).

Enrollment: 164 estimated patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

air temperature control (ATC)

Active Comparator group

Description:

Incubator control using air temperature control (ATC) method

Treatment:

Procedure: air temperature control (ATC)

skin servocontrol (SSC)

Active Comparator group

Description:

Incubator control using skin servocontrol method

Treatment:

Procedure: skin servocontrol (SSC)