NCT07453264 Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding
| NCT ID | NCT07453264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University - Cerrahpasa |
| Condition | Thermoregulation |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-11-01 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Maintaining neonatal body temperature (thermoregulation), particularly during the first hour after birth, is critical for survival and successful adaptation to the extrauterine environment. Implementation of a thermoregulation bundle is expected to facilitate faster stabilization of physiological parameters and to positively influence the initiation of breastfeeding as well as overall breastfeeding success. The effects of a thermoregulation bundle applied at birth on neonatal physiological parameters-including body temperature, respiratory rate, heart rate, and oxygen saturation-and on breastfeeding outcomes will be evaluated.
Eligibility Criteria
Inclusion Criteria: * The baby is born vaginally * It is a singleton pregnancy, * The baby is born at term (gestational age 38-42 weeks), * The baby's Apgar score is ≥ 7 at 1 minute, * The baby's birth weight is between 2500-4000 grams, * The baby is exclusively breastfed, * The baby has no problems preventing breastfeeding, * The mother has no problems preventing breastfeeding, * There are no maternal or fetal complications. Exclusion Criteria: * The baby being preterm/postterm, * Starting formula feeding, * The baby having special care needs (intensive care, etc.), * The baby having intrauterine growth restriction (IUGR), genetic disease, etc.
Contact & Investigator
gülçin bozkurt, Professor Doctor
STUDY DIRECTOR
istanbul üniversitesi cerrahpaşa sağlık bilimleri fakültesi
Frequently Asked Questions
Who can join the NCT07453264 clinical trial?
This trial is open to participants of all sexes, aged 2 Hours or older, up to 2 Hours, studying Thermoregulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07453264 currently recruiting?
Yes, NCT07453264 is actively recruiting participants. Contact the research team at yesimdilki@ogr.iuc.edu.tr for enrollment information.
Where is the NCT07453264 trial being conducted?
This trial is being conducted at Kocaeli, Turkey (Türkiye).
Who is sponsoring the NCT07453264 clinical trial?
NCT07453264 is sponsored by Istanbul University - Cerrahpasa. The principal investigator is gülçin bozkurt, Professor Doctor at istanbul üniversitesi cerrahpaşa sağlık bilimleri fakültesi. The trial plans to enroll 140 participants.