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Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding

StatusRecruiting
PhaseNot applicable
Started2025-11-01
View on ClinicalTrials.gov ↗

Amendment history

2026-05-03
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v1
Secondary endpoints3 to 7 entries
Apgar score Oxygen saturation (SpO₂) Heart rate Respiratory rate
Study description-576 characters
Bu akademik metnin İngilizce çevirisi aşağıdadır. Terimlerin uluslararası literatüre (WHO ve Neonatoloji protokolleri) uygun olmasına özen gösterilmiştir.Translation: Thermoregulation in Newborns and the Care Bundle ApproachThe [...] ithin specific ranges despite changes in ambient temperature (Loring et al., 2012). Maintaining the newborn's body temperature, particularly w [...] ypoglycemia, respiratory distress, and delayed breastfeeding (Smith, 2024). Preventing neonatal hypothermia in the delivery room stand [...] as a cost-effective approach to reducing neonatal mortality (World Health Organization [WHO], 19 [...] [...]
Study sitesdetails revised at 1 of 1 site
2026-03-02
Original filing
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.
Trial Details
NCT Number NCT07453264
Lead Sponsor Istanbul University - Cerrahpasa
Conditions Thermoregulation, Neonatal Hypothermia, Neonatal Adaptation
Enrollment 140 participants
Start Date 2025-11-01
Primary Completion 2026-03-30 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-05