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