Management and Thermal Comfort of Premature Infants Under 32 Weeks (NCT03648606) | Clinical Trial Compass
CompletedNot Applicable
Management and Thermal Comfort of Premature Infants Under 32 Weeks
France29 participantsStarted 2010-06-04
Plain-language summary
Sleep propensity was assessed in terms of the duration of a spontaneous episode of wakefulness (W). Skin temperatures at six body sites (the abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates (postmenstrual age: 209 9 days). Te investigators then determined whether the duration of the W episode depended upon the local skin temperatures measured at the start, during and end of the episode.
Who can participate
Age range
1 Day – 10 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* premature newborns 25 to 32 weeks of amenorrhea;
* arrival in the Neonatal Medicine Unit \<12 hours of life;
* need for management in a closed incubator;
* availability of an incubator equipped with communication card.
Exclusion Criteria:
* premature newborns\> 32 weeks of amenorrhea;
* arrival in the Neonatal Medicine unit after 12 hours of life;
* presence of malformation syndrome or serious heart disease;
* pathology requiring management within the first 10 days of life;
* Apgar score \<5 at 10 minutes of life;
* need for initial management in an open incubator;
* unavailability of an incubator equipped with a communication card
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mesure of the Thermal confort of preterm infants less than 32 weeks