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RECRUITING
NCT03919188
NA

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

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

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).

Official title: Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity

Key Details

Gender

All

Age Range

Any - 1 Day

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2022-01-01

Completion Date

2025-12

Last Updated

2025-05-29

Healthy Volunteers

No

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).

Locations (1)

Amiens University Hospital

Amiens, Picardie, France