ThermoregulationNCT07453264
Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding
A study testing Thermoregulation bundle and routine care in people with Thermoregulation and Neonatal Hypothermia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Maintaining neonatal body temperature (thermoregulation), particularly during the first hour after birth, is critical for survival and successful adaptation to the extrauterine environment. Read more about this study
- Who is it for?
- Ages 2 to 2 hours
- Conditions the study is for
- Thermoregulation, Neonatal Hypothermia, Neonatal Adaptation
- What is being tested?
- Thermoregulation bundle and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 2 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
Show all 9Show fewer
- The baby has no problems preventing breastfeeding,
- The mother has no problems preventing breastfeeding,
- There are no maternal or fetal complications.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi
Kocaeli, darıca, 41000
yeşim dilki, student, +905010732834, yesimdilki@ogr.iuc.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Thermoregulation, Neonatal Hypothermia, Neonatal Adaptation
- Being tested
- Thermoregulation bundle, routine care
- Keywords
- thermoregulation bundle, term newborn, neonatal hypothermia, skin-to-skin contact, delivery room care, physiological parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoregulation bundleOther
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.
routine careOther
Standard delivery room care according to institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| THERMOREGULATION BUNDLE GROUP | Experimental | Newborns in this group will receive a Thermoregulation Package immediately after birth. The package includes the following:
1. The delivery room temperature should be between 23-26 degrees Celsius.
2. Skin-to-skin contact should be initiated as soon as the baby is born.
3. The baby should be dried starting from the head with a warm towel and a hat should be put on.
4. The baby should be covered with a warm towel during skin-to-skin contact.
5. 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. Receives: Other: Thermoregulation bundle |
| CONTROL GROUP | Other | Newborns in this group will receive routine delivery room care according to the standard hospital protocol. No structured thermoregulation bundle will be applied. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal body temperature stability
Body temperature (°C) of the newborn measured at 1, 5, 30, and 60 minutes after birth.
Measured: with in first 60 minutes postpartum
Secondary outcomes (7)
time to first breastfeeding
The time (in minutes) from birth to the first successful latch
Measured: within first 1 hours postpartum
Early Breastfeeding Success
Breastfeeding success assessed using the LATCH breastfeeding assessment tool.
Measured: Within the first 1 hours postpartum
incidence of neonatal hypothermia
The proportion of newborns with axillary temperature <36.5°C.
Measured: 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.
Measured: At 1 and 5 minutes after birth
Oxygen saturation (SpO₂)
Peripheral oxygen saturation (%) measured at 1, 5, 30, and 60 minutes after birth.
Measured: Within the first 60 minutes after birth
Heart rate
Heart rate (beats per minute) measured at 1, 5, 30, and 60 minutes after birth.
Measured: Within the first 60 minutes after birth
Respiratory rate
Respiratory rate (breaths per minute) measured at 1, 5, 30, and 60 minutes after birth.
Measured: Within the first 60 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Nov 2025
- Primary completion30 Mar 2026
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThermoregulationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the thermoregulation bundle group or the routine care group in a parallel design. The intervention will be applied immediately after birth during the first hour of life. Outcomes will be compared between groups.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yeşim dilki, Istanbul University - Cerrahpasa
- Investigators
- gülçin bozkurt, Professor Doctor, Study director, istanbul üniversitesi cerrahpaşa sağlık bilimleri fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453264
- Sponsor's protocol ID
- IstanbulUC-SBF-YD-01
- Status last verified
- May 2026
- First submitted
- 2 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study can be shared by the researcher once it is completed.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07453264
- Acronym / sponsor ID
- IstanbulUC-SBF-YD-01
- Conditions
- Thermoregulation, Neonatal Hypothermia, Neonatal Adaptation
- Keywords
- thermoregulation bundle, term newborn, neonatal hypothermia, skin-to-skin contact, delivery room care, physiological parameters
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the thermoregulation bundle group or the routine care group in a parallel design. The intervention will be applied immediately after birth during the first hour of life. Outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| THERMOREGULATION BUNDLE GROUP | Experimental | Other: Thermoregulation bundleNewborns in this group will receive a Thermoregulation Package immediately after birth. The package includes the following: 1. The delivery room temperature should be between 23-26 degrees Celsius. 2. Skin-to-skin contact should be initiated as soon as the baby is born. 3. The baby should be dried starting from the head with a warm towel and a hat should be put on. 4. The baby should be covered with a warm towel during skin-to-skin contact. 5. 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. |
| CONTROL GROUP | Other | Other: routine careNewborns in this group will receive routine delivery room care according to the standard hospital protocol. No structured thermoregulation bundle will be applied. |
Who may qualify
- Ages
- 2 to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermoregulation bundleA 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 | THERMOREGULATION BUNDLE GROUP |
| routine careStandard delivery room care according to institutional protocol. | Other | CONTROL GROUP |
Primary outcome
neonatal body temperature stability
Time frame: with in first 60 minutes postpartum
Body temperature (°C) of the newborn measured at 1, 5, 30, and 60 minutes after birth.
7 secondary outcomes
time to first breastfeeding
Time frame: within first 1 hours postpartum
Early Breastfeeding Success
Time frame: Within the first 1 hours postpartum
incidence of neonatal hypothermia
Time frame: Within the first 60 minutes after birth
Apgar score
Time frame: At 1 and 5 minutes after birth
Oxygen saturation (SpO₂)
Time frame: Within the first 60 minutes after birth
Heart rate
Time frame: Within the first 60 minutes after birth
Respiratory rate
Time frame: Within the first 60 minutes after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. The study can be shared by the researcher once it is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
gülçin bozkurt, Professor Doctor study director
istanbul üniversitesi cerrahpaşa sağlık bilimleri fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoregulation bundle and routine care in people with Thermoregulation and Neonatal Hypothermia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yeşim dilki, student (+905010732834, yesimdilki@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal body temperature stability (time frame: with in first 60 minutes postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.