Monitoring body temperature in newborns during skin-to-skin care after cesarean delivery
Continuous Monitoring of Body Temperature in Neonates During Skin-to-skin Care Immediately After Cesarean Section (MonT Neo) - a Prospective Observational Pilot Study
This study is testing a new way to keep track of newborns' body temperature during skin-to-skin care after a cesarean delivery to see if it works as well as the traditional method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT06632769 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to continuously monitor the body temperature of term neonates using the SteadyTemp® adhesive thermometer during skin-to-skin care immediately after cesarean section. The study will compare the continuous temperature data with a single manual rectal temperature measurement, which serves as the gold standard. Additionally, the skin condition under the adhesive patch will be assessed after 15 minutes of application using the Neonatal Skin Condition Scale. The goal is to evaluate the effectiveness and safety of this non-invasive monitoring method.
Who should consider this trial
Good fit: Ideal candidates for this study are term neonates who are receiving skin-to-skin care immediately after a cesarean section.
Not a fit: Patients who are preterm, require respiratory support, or have congenital malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the monitoring of body temperature in newborns, enhancing their safety during skin-to-skin care.
How similar studies have performed: While similar approaches to monitoring body temperature in neonates have been explored, this specific method using the SteadyTemp® thermometer is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Term neonates after caesarean section receiving skin-to-skin care immediately after birth * Parental written informed consent Exclusion Criteria: * Preterm birth * Need for respiratory support after birth * No decision to conduct full life support * No written informed consent * Congenital malformation
Where this trial is running
Graz, Styria
- Medical University Graz — Graz, Styria, Austria (Recruiting)
Study contacts
- Study coordinator: Nariae Baik-Schneditz, MD. PhD.
- Email: nariae.baik@medunigraz.at
- Phone: +4331638582677
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.