Comparing air temperature control and skin control for preterm infants in incubators
Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity
NA · Centre Hospitalier Universitaire, Amiens · NCT03919188
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | N/A to 1 Day |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens (other) |
| Locations | 1 site (Amiens, Picardie) |
| Trial ID | NCT03919188 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with serious heart disease or polymalformative syndromes may not benefit from this study.
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 performed: Previous studies have shown promising results with similar temperature management approaches in preterm infants.
Eligibility criteria
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 this trial is running
Amiens, Picardie
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Infant, Body Temperature, preterm neonates, incubator management, body temperature, relative air humidity, thermoneutrality