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

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Adaptation; Thermoregulation; Neonatal Hypothermia
• Intervention / Treatment: Other: Thermoregulation bundle; Other: routine care

Detailed Description

Thermoregulation in Newborns and the Care Bundle ApproachThermoregulation is the ability to maintain body temperature within specific ranges despite changes in ambient temperature. 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. Preventing neonatal hypothermia in the delivery room stands out as a cost-effective approach to reducing neonatal mortality.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. Subcutaneous fat constitutes 2-6% of a newborn's body weight, and they utilize this tissue to maintain thermal balance. Because their surface area-to-weight ratio is significantly higher than that of adults, newborns lose heat four times faster. Hypothermia is an independent risk factor that affects multiple systems and increases neonatal morbidity and mortality. 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. 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.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 . 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. According to the World Health Organization's recommendations, the temperature in the delivery room should be between 23-25°C. 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 .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. 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 . 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 . 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yeşim dilki, student; Phone Number: +905010732834; Email: yesimdilki@ogr.iuc.edu.tr
• Study Contact Backup: Name: gülçin bozkurt, Professor Doctor; Phone Number: +905336349093; Email: gbozkurt@iuc.edu.tr

Study Locations

• Turkey (Türkiye)
  • darıca
    • Kocaeli, darıca, Turkey (Türkiye), 41000
      • Recruiting
      • Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi
      • Contact: yeşim dilki, student; Phone Number: +905010732834; Email: yesimdilki@ogr.iuc.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THERMOREGULATION BUNDLE GROUP; Newborns in this group will receive a Thermoregulation Package immediately after birth. The package includes the following: The delivery room temperature should be between 23-26 degrees Celsius.; Skin-to-skin contact should be initiated as soon as the baby is born.; The baby should be dried starting from the head with a warm towel and a hat should be put on.; The baby should be covered with a warm towel during skin-to-skin contact.; The baby should be breastfed immediately (within the first 30-60 minutes). All components of the package will be applied according to an all-or-nothing approach.	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: CONTROL GROUP; Newborns in this group will receive routine delivery room care according to the standard hospital protocol. No structured thermoregulation bundle will be applied.	Other: routine care; Standard delivery room care according to institutional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal body temperature stability	Body temperature (°C) of the newborn measured at 1, 5, 30, and 60 minutes after birth.	with in first 60 minutes postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first breastfeeding	The time (in minutes) from birth to the first successful latch	within first 1 hours postpartum
Early Breastfeeding Success	Breastfeeding success assessed using the LATCH breastfeeding assessment tool.	Within the first 1 hours postpartum
incidence of neonatal hypothermia	The proportion of newborns with axillary temperature <36.5°C.	Within the first 60 minutes after birth
Apgar score	Assessed at 1 and 5 minutes after birth using the Apgar scoring system (range: 0-10). Higher scores indicate better neonatal condition.	At 1 and 5 minutes after birth
Oxygen saturation (SpO₂)	Peripheral oxygen saturation (%) measured at 1, 5, 30, and 60 minutes after birth.	Within the first 60 minutes after birth
Heart rate	Heart rate (beats per minute) measured at 1, 5, 30, and 60 minutes after birth.	Within the first 60 minutes after birth
Respiratory rate	Respiratory rate (breaths per minute) measured at 1, 5, 30, and 60 minutes after birth.	Within the first 60 minutes after birth

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Study Director: gülçin bozkurt, Professor Doctor, istanbul üniversitesi cerrahpaşa sağlık bilimleri fakültesi

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Actual): March 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: term newborn; physiological parameters; neonatal hypothermia; skin-to-skin contact; thermoregulation bundle; delivery room care
• Other Study ID Numbers: IstanbulUC-SBF-YD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study can be shared by the researcher once it is completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No