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RECRUITING
NCT07453264
NA

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

Sponsor: Istanbul University - Cerrahpasa

View on ClinicalTrials.gov

Summary

Maintaining the infant's body temperature (thermoregulation), particularly in the first hour after birth, is critical for the newborn's survival and adaptation to the environment. It is hypothesized that the implementation of a thermoregulation bundle will lead to a faster stabilization of physiological parameters and will positively influence the initiation and overall success of breastfeeding. To this end, this study will examine the effects of a thermoregulation bundle applied at birth on the physiological parameters of newborns (vital signs such as body temperature, respiratory rate, heart rate, and oxygen saturation) and its impact on breastfeeding.

Official title: Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

0 Days - 2 Hours

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-11-01

Completion Date

2026-08-30

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

OTHER

Thermoregulation bundle

A structured set of evidence-based thermal care interventions applied immediately after birth, including maintaining appropriate delivery room temperature, immediate drying with warm linens, removal of wet towels, application of a hat, early skin-to-skin contact for the first hour, and covering the newborn with a warm blanket. The bundle is implemented using an all-or-nothing approach.

OTHER

routine care

Standard delivery room care according to institutional protocol.

Locations (1)

Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi

Kocaeli, Darıca, Turkey (Türkiye)