Comparing air temperature control and skin control for preterm infants in incubators
Official title: Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity
Run by Centre Hospitalier Universitaire, Amiens · NCT03919188 · Data updated 2026-11-12
This study is testing whether keeping preterm babies warm with air temperature control or skin control in incubators helps them grow better and stay healthier during their first ten days of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 1 Day |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens, Picardie) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | May 29, 2025 |
| Trial ID | NCT03919188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are preterm infants born between 25 and 32 weeks of gestation who are admitted to the hospital within the first 24 hours of life.
✕Probably not a fit
Patients with serious heart disease or polymalformative syndromes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of two different temperature management methods in incubators for preterm infants born between 25 and 32 weeks of gestation. One method uses a software to calculate and maintain an optimal air temperature to minimize body heat loss, while the other relies on skin servocontrol. The goal is to determine which method better supports weight growth and reduces morbidity and mortality in these vulnerable infants during their first ten days of life. The study will enroll infants within the first 24 hours of life and will require parental consent.
Why it matters
Potential benefit: If successful, this study could lead to improved growth and reduced health complications for preterm infants.
How similar studies have gone: Previous studies have shown promising results with similar temperature management approaches in preterm infants.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Amiens University Hospital
Amiens, Picardie, France Recruiting
Study contacts
- Principal investigator: Alexandre Cénéric, Dr — University Hospital, Caen
- Study coordinator: Pierre Tourneux, Pr
- Email: tourneux.pierre@chu-amiens.fr
- Phone: (33)322087604
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Detection of Respiratory Events in Extremely Preterm Infants Using Acoustic Monitoring
A new acoustic monitoring approach is being tested to detect breathing problems in very preterm babies to help NICU teams spot and manage apnea and related events.
-
Early Nutrition Support for Extremely Preterm Infants
This initiative tests a nutrition bundle—personalized breast milk feeding, early zinc supplementation, and routine carnitine supplementation—for very preterm babies to see if it improves growth and development.
-
Using bubble CPAP sounds to measure airway pressure in premature infants
This project will try to see if the sounds made by bubble CPAP can tell us how much airway pressure very premature infants (born before 32 weeks) are actually receiving.
-
Early lung development in preterm babies with and without fetal growth restriction
This study will test whether ultrasound measurements of fetal lung volume, diaphragm thickness and heart function before 32 weeks can help predict breathing problems and later lung function in preterm babies with or without fetal growth restriction.
-
Impact of a non-invasive ventilation method on very preterm infants
This study is testing a new breathing support method for very preterm infants to see if it helps them do better in the short and long term.
-
Positive feeding for preterm babies
This study will try a cue-based, parent-led feeding approach for preterm infants in the NICU to see if it can be put into practice and is acceptable to parents and staff.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.