Actively Recruiting
Comparison of Air vs. Cutaneous Control Mode for Preterm Infants 64 32 Weeks Gestation in Closed Incubators: Impact on Body Growth and Morbidity
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-29
164
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
U
University Hospital, Rouen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying preterm infants born between 25 and 32 weeks of gestation to compare two methods of incubator temperature control and their effects on infant weight growth and health. The study is based on earlier findings that lower body temperature on admission relates to higher illness and death rates in preterm infants. It aims to see if using a new software to calculate personalized air temperature in incubators can improve growth and reduce side effects compared to the traditional skin temperature control method. The study compares two incubator control methods: air temperature control (ATC), which uses software to set air temperature to reduce body heat loss to zero, and skin servocontrol (SSC), which adjusts incubator temperature based on the infant's skin temperature. Both methods are evaluated in closed incubators for preterm infants. The trial randomly assigns infants to one of these two methods to study their effects during the first 10 days of life. Participants will be monitored for changes in body weight until day 10, along with comfort, thermal stress, and humidity challenges. The study also tracks neonatal illness occurrences up to 40 weeks of amenorrhea and length of hospital stay until discharge or 40 weeks of amenorrhea. Parents provide written consent, and infants are included within the first day of life. The study continues through hospitalization, assessing health outcomes and safety related to the incubator settings.
CONDITIONS
Brief Title
Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 parents
You will not qualify if you...
- Newborn infant with polymalformative syndrome
- Life threatening events or serious heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 24 hours after birth
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until day 10 of life
Participants receive incubator care using either air temperature control (ATC) or skin servocontrol (SSC) methods.
Daily in-person visits for up to 10 days
Duration - Until 40 weeks of amenorrhea or end of hospitalization
Participants are monitored for neonatal morbidity and length of hospitalization until reaching 40 weeks of amenorrhea or discharge.
Regular visits until discharge or 40 weeks of amenorrhea
Trial Site Locations
Total: 1 location
1
Amiens University Hospital
Amiens, Picardie, France, 80054
Actively Recruiting
Research Team
P
Pierre Tourneux, Pr
M
Momar Diouf, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here