NCT07453264

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 0 Days – 2 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

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 ApproachThermoregulation is the ability to maintain body temperature within specific ranges despite changes in ambient temperature (Loring et al., 2012). Maintaining the newborn's body temperature, particularly within the first hour after birth, is critical for survival and adaptation to the external environment. When thermoregulation cannot be achieved during this first hour-often referred to as the "Golden Hour"-it can lead to adverse outcomes such as hypothermia, hypoglycemia, respiratory distress, and delayed breastfeeding (Smith, 2024). Preventing neonatal hypothermia in the delivery room stands out as a cost-effective approach to reducing neonatal mortality (World Health Organization \[WHO\], 1997).Maintaining a stable body temperature is challenging for newborns. They are at high risk for hypothermia due to weak subcutaneous fat tissue, a high body surface area-to-weight ratio, and the immaturity of the nervous and cardiovascular systems involved in heat production (Aydın \& Güneş, 2022; Conk, Başbakkal, Bal-Yılmaz \& Bolışık, 2013). Subcutaneous fat constitutes 2-6% of a newborn's body weight, and they utilize this tissue to maintain thermal balance (Aydın \& Güneş, 2022). Because their surface area-to-weight ratio is significantly higher than that of adults, newborns lose heat four times faster (Chamberlain et al., 2019; George et al., 2015). Hypothermia is an independent risk factor that affects multiple systems and increases neonatal morbidity and mortality (Mishra et al., 2024; Madar et al., 2021; Smith, 2024).Thermoregulation, which is vital in neonatal care, ensures the maintenance of normal body temperature by balancing heat production and heat loss. The normal body temperature for newborns should be maintained between 36.5°C and 37.5°C (Mishra et al., 2024; Madar et al., 2021). To optimize this, the WHO recommends that delivery rooms be kept between 25°C and 28°C (77°F-82.4°F). Maintaining the room temperature within the recommended range is of vital importance, as the newborn increases oxygen and energy consumption when unable to keep body temperature within normal limits (Aydın \& Güneş, 2022).To prevent hypothermia and support breastfeeding in healthy newborns, the WHO recommends skin-to-skin contact with the mother for the first hour after birth and dressing the baby appropriately for the ambient temperature. This typically means using twice as many layers as an adult, including a hat (WHO, 2018). The Turkish Neonatology Society's delivery room management guidelines prioritize heating and drying over positioning the head and aspiration. In newborns, a body temperature of $\<36.0°C$ is considered hypothermia, while $\>38°C$ is considered hyperthermia. It is recommended that delivery room temperatures be 23-25°C, aligned with WHO suggestions.For term infants, the guidelines suggest drying the baby with warm, dry linens starting from the head, removing wet linens immediately, and placing a hat that covers the ears. Healthy term infants should be placed in skin-to-skin contact on the mother's chest, facing her, with their backs covered by a warm blanket. Unless respiratory support is required, these infants do not need to be placed under a radiant warmer. If respiratory support is provided, ensuring the air is humidified and heated is crucial for preventing hypothermia. The use of radiant warmers for term and preterm infants born with moderate-to-severe hypoxic-ischemic encephalopathy should be carefully evaluated. Furthermore, the Turkish Neonatology Society explicitly states that hot water bottles, surgical gloves filled with hot water, or bags should never be used to warm the baby, as they may cause burns (Turkish Neonatology Society, 2021).In a study examining the success of thermoregulation on breastfeeding, it was observed that newborns' body temperatures increased during the nursing process. In the experimental group, infants were breastfed in a room at 22-25°C with reduced clothing (only a bodysuit and diaper), while the control group breastfed in the same room temperature with their existing clothes. The study found that newborns in the experimental group (reduced clothing) breastfed for longer durations on the first day (Gözlüklü, 2022).Interventions to support thermoregulation have been shown to prevent both neonatal hypothermia and hyperthermia. Procedures performed in the first hours after birth must be carried out with correct timing and sequence to support thermal regulation (Sobel et al., 2011). In the literature, there is a lack of studies examining the effects of a "Thermoregulation Bundle" specifically for term infants. A "Care Bundle" approach involves the simultaneous and complete application of a small set of evidence-based interventions (usually 3-5) that have been scientifically proven to improve patient outcomes. These bundles are typically applied following an "all-or-nothing" rule; if one element is missed, the entire bundle is considered incomplete (Bozkurt 2017; Kim et al., 2018).A thermoregulation bundle is a cost-effective approach that ensures evidence-based and standardized thermal care after birth. The results obtained from this research are expected to provide evidence for interventions aimed at maintaining newborn temperature in the delivery room, thereby supporting neonatal health and successful breastfeeding.

Conditions

• Thermoregulation
• Neonatal Hypothermia
• Neonatal Adaptation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-03-30
• Completion: 2026-08-30
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: Turkey (Türkiye)