NCT03919188 Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
| NCT ID | NCT03919188 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Preterm Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2022-01-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Alexandre Cénéric, Dr
PRINCIPAL INVESTIGATOR
University Hospital, Caen
Frequently Asked Questions
Who can join the NCT03919188 clinical trial?
This trial is open to participants of all sexes, up to 1 Day, studying Preterm Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03919188 currently recruiting?
Yes, NCT03919188 is actively recruiting participants. Contact the research team at tourneux.pierre@chu-amiens.fr for enrollment information.
Where is the NCT03919188 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT03919188 clinical trial?
NCT03919188 is sponsored by Centre Hospitalier Universitaire, Amiens. The principal investigator is Alexandre Cénéric, Dr at University Hospital, Caen. The trial plans to enroll 164 participants.