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

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).

Conditions

• Preterm Infant
• Body Temperature

Interventions

PROCEDURE

air 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)

PROCEDURE

skin 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 & Collaborators

• University Hospital, Rouen

  collaborator OTHER

• University Hospital, Caen

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• Centre Hospitalier Arras

  collaborator OTHER

• Centre Hospitalier de Montreuil

  collaborator UNKNOWN

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Principal Investigators

• Alexandre Cénéric, Dr · CHU CAEN

• Kévin Leduc, Dr · CHRU LILLE

• Sophie Galène, MD · CHU Rouen

• Guillaume ESCOURROU, MD · CHI André Grégoire - Montreuil

• Julien Ghesquière, MD · CH Arras

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

1 Day

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• France

Study Locations