Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: air temperature control (ATC), skin servocontrol (SSC).
- Who it may be relevant to
- Registry conditions: Preterm Infant, Body Temperature. Basic parameters: up to 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity
Overview
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).
Interventions
- Procedure air temperature control (ATC)
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): second parameter : air temperature control (ATC) - Procedure skin servocontrol (SSC)
Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): Third parameter : skin servocontrol (SSC).
Primary outcome measures
- Change in body weight [Time frame: until day 10 of life]
Secondary outcome measures (5)
- Comfort of the preterm infant [Time frame: until day 10 of life]
- thermal stress occurence [Time frame: until day 10 of life]
- humidity challenge using TEWL [Time frame: until day 10 of life]
- neonatal morbidity occurence [Time frame: until age corresponding to 40 weeks of amenorrhea]
- length of hospitalization stay [Time frame: until age corresponding to 40 weeks of amenorrhea or end of hospitalization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Amiens University Hospital — Amiens
Identifiers
NCT: NCT03919188 · PI2018_843_0056