RecruitingNot ApplicableNCT03919188

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

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


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

164 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Max Age: 1 Day

Inclusion Criteria4

  • 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 Criteria2

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

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Interventions

PROCEDUREair 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)

PROCEDUREskin 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

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NCT03919188


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