Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Newborn infant with polymalformative syndrome
- Life threatening events or serious heart disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Amiens University Hospital
Amiens, Picardie, France, 80054
Actively Recruiting
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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