Skip to main content
Clinical Trials/NCT03919188
NCT03919188
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country164 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Infant
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
164
Locations
1
Primary Endpoint
Change in body weight
Status
Recruiting
Last Updated
11 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in body weight

Time Frame: until day 10 of life

Change in body weight between birth and day 10 of life

Secondary Outcomes

  • humidity challenge using TEWL(until day 10 of life)
  • length of hospitalization stay(until age corresponding to 40 weeks of amenorrhea or end of hospitalization)
  • Comfort of the preterm infant(until day 10 of life)
  • thermal stress occurence(until day 10 of life)
  • neonatal morbidity occurence(until age corresponding to 40 weeks of amenorrhea)

Study Sites (1)

Loading locations...

Similar Trials