Clinical trial NCT03919188: Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
Official title: Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Infant
Body Temperature
Keywords: preterm neonates
incubator management
body temperature
relative air humidity
thermoneutrality
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Rouen
name: University Hospital, Caen
name: University Hospital, Lille
name: Centre Hospitalier Arras
name: Centre Hospitalier de Montreuil
First posted: 2019-04-18
Enrollment: 164
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: Change in body weight
timeFrame: until day 10 of life
Secondary outcomes:
measure: Comfort of the preterm infant
timeFrame: until day 10 of life
measure: thermal stress occurence
timeFrame: until day 10 of life
measure: humidity challenge using TEWL
timeFrame: until day 10 of life
measure: neonatal morbidity occurence
timeFrame: until age corresponding to 40 weeks of amenorrhea
measure: length of hospitalization stay
timeFrame: until age corresponding to 40 weeks of amenorrhea or end of hospitalization
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
state: Picardie
Study officials:
affiliation: CHU CAEN
name: Alexandre Cénéric, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU LILLE
name: Kévin Leduc, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Sophie Galène, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHI André Grégoire - Montreuil
name: Guillaume ESCOURROU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Arras
name: Julien Ghesquière, MD
role: PRINCIPAL_INVESTIGATOR
References: