Actively Recruiting

Phase Not Applicable
Age: 0 - 1Day
All Genders
NCT03919188

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-29

164

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire, Amiens

Lead Sponsor

U

University Hospital, Rouen

Collaborating Sponsor

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 1Day
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infant born between 25+0 and 32+0 weeks of gestation
  • Included in the study before 24 +/- 12 hours of life
  • Nursed in a closed incubator
  • Written informed consent from parents
Not Eligible

You will not qualify if you...

  • Newborn infant with polymalformative syndrome
  • Life threatening events or serious heart disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amiens University Hospital

Amiens, Picardie, France, 80054

Actively Recruiting

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Research Team

P

Pierre Tourneux, Pr

CONTACT

M

Momar Diouf, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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