TemperatureNCT07176364
Body Temperature in Preterm Neonates: Creating a Data Model
An observational study of Temperature and Preterm, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the relationship between the characteristics, medical history, interventions performed within the first six hours, and follow-up findings of preterm newborns receiving respiratory support and their body temperature. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Temperature, Preterm
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2025to 9 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm newborns hospitalized in the Neonatal Intensive Care Unit at Acıbadem Healthcare Group Hospitals in Istanbul
Who may be able to join
- Preterm newborns born before 38 weeks of gestation and immediately admitted to the neonatal intensive care unit after birth
- who received respiratory support
Who cannot join
- Newborns who did not receive respiratory support immediately after birth despite being preterm at gestational age
- who have developmental health problems
- who have congenital health problems
- who were transferred from another healthcare facility after birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Temperature Monitoring and Factors Affecting Body Temperature in Preterm Neonates Receiving Respiratory Support: Creating a Data Model
The aim of this study is to examine the relationship between the characteristics, medical history, interventions performed within the first six hours, and follow-up findings of preterm newborns receiving respiratory support and their body temperature. In this context, the aim was to establish a basic data model that would contribute to the optimization of practices aimed at maintaining thermoregulation in newborns receiving respiratory support.
H1: The characteristics, medical history, and variables related to the interventions performed in preterm newborns receiving respiratory support have a statistically significant relationship with body temperature.
H2: The developed data model can accurately and meaningfully predict the relationship between the characteristics, medical history, and interventions affecting body temperature in preterm newborns receiving respiratory support.
Read the detailed description
Because the systems of preterm infants are not functionally mature, deficiencies are seen in critical physiological processes such as respiration and thermoregulation. Since respiratory functions are not fully developed, increased respiratory effort can increase energy expenditure and metabolic load, making it difficult to regulate body temperature and facilitate postnatal adaptation.
Increased respiratory effort can create a metabolic load that may increase the risk of hypothermia in preterm infants. In preterm infants experiencing respiratory distress, energy consumption increases, while the energy reserves necessary to maintain body temperature may be depleted more rapidly. As a result, thermoregulation may not be maintained, and the risk of hypothermia may increase. Furthermore, factors that increase respiratory effort may elevate oxygen demand, leading to changes in blood circulation and disruption of thermoregulatory mechanisms.
Maintaining normothermia in newborns is critically important and is known to have a direct impact on survival. The World Health Organization recognizes maintaining normothermia as a fundamental and critical component of newborn care.
Studies have shown that respiratory support interventions and care methods aimed at preventing hypothermia in preterm newborns reduce respiratory workload and help maintain more stable body temperature. Furthermore, the effects of non-invasive ventilation and nasal continuous positive airway pressure on body temperature in preterm infants requiring respiratory support have been examined, and it has been emphasized that the results need to be thoroughly evaluated in terms of thermoregulation.
In this context, our study aims to examine the relationship between body temperature and the characteristics, medical history, interventions performed within the first six hours, and follow-up findings of preterm newborns receiving respiratory support. By evaluating the relationships between variables in preterm infants receiving different types of respiratory support, a fundamental data model will be created that will contribute to optimizing practices aimed at maintaining thermoregulation. The results obtained may guide clinical practice by contributing to the development of appropriate thermoregulation management strategies in neonatal intensive care units, thereby reducing the risk of hypothermia.
- Conditions
- Temperature, Preterm
- Keywords
- PRETERM, TEMPERATURE, INFANT, DECISION TREE, VENTILATION
- Medical subject headings
- Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infant | Preterm infants born before 38 weeks of gestation who were immediately admitted to the neonatal intensive care unit after birth and received respiratory support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body temperature
Body temperature measurement evaluated as axillary. Data for premature infants were collected hourly immediately after birth and for 6 hours following birth.
Measured: At birth and every hour for up to 6 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start14 Apr 2025
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TemperatureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
- Investigators
- Zehra Kan Öntürk, Assoc. Prof., Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176364
- Sponsor's protocol ID
- ATADEK-2025/05
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Getaneh FB, Misganaw NM, Mihretie DB, Bitew ZW. Admission Hypothermia and Factors Associated with Mortality among Admitted Hypothermic Preterm Neonates in Neonatal Intensive Care Units of Public Hospitals of Addis Ababa, Ethiopia. Int J Pediatr. 2022 Oct 8;2022:8078628. doi: 10.1155/2022/8078628. eCollection 2022.
PubMed 36254265Feyisa GT, Marami SN, Dinagde DD, Degefe BD, Abebe ST, Kitil GW, Biratu AK. Comparative study of neonatal hypothermia and associated factors among neonates in rural and urban areas of the Shebadino Woreda, Sidama region, Southern Ethiopia: a community-based comparative cross-sectional study. BMC Public Health. 2024 Jul 20;24(1):1945. doi: 10.1186/s12889-024-19504-8.
PubMed 39033283Nyandiko WM, Kiptoon P, Lubuya FA. Neonatal hypothermia and adherence to World Health Organisation thermal care guidelines among newborns at Moi Teaching and Referral Hospital, Kenya. PLoS One. 2021 Mar 23;16(3):e0248838. doi: 10.1371/journal.pone.0248838. eCollection 2021.
PubMed 33755686Mohamed SOO, Ahmed SMI, Khidir RJY, Shaheen MTHA, Adam MHM, Ibrahim BAY, Elmahdi EOA, Farah ASM. Outcomes of neonatal hypothermia among very low birth weight infants: a Meta-analysis. Matern Health Neonatol Perinatol. 2021 Sep 15;7(1):14. doi: 10.1186/s40748-021-00134-6.
PubMed 34526138Demtse AG, Pfister RE, Nigussie AK, McClure EM, Ferede YG, Tazu Bonger Z, Mekasha A, Demisse AG, Gidi NW, Metaferia G, Worku B, Goldenberg RL, Muhe LM. Hypothermia in Preterm Newborns: Impact on Survival. Glob Pediatr Health. 2020 Sep 13;7:2333794X20957655. doi: 10.1177/2333794X20957655. eCollection 2020.
PubMed 32974416
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Temperature Monitoring and Factors Affecting Body Temperature in Preterm Neonates Receiving Respiratory Support: Creating a Data Model
- ClinicalTrials.gov ID
- NCT07176364
- Acronym / sponsor ID
- ATADEK-2025/05
- Conditions
- Temperature, Preterm
- Keywords
- PRETERM, TEMPERATURE, INFANT, DECISION TREE, VENTILATION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 16 Sep 2025 (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.
The aim of this study is to examine the relationship between the characteristics, medical history, interventions performed within the first six hours, and follow-up findings of preterm newborns receiving respiratory support and their body temperature. In this context, the aim was to establish a basic data model that would contribute to the optimization of practices aimed at maintaining thermoregulation in newborns receiving respiratory support.
H1: The characteristics, medical history, and variables related to the interventions performed in preterm newborns receiving respiratory support have a statistically significant relationship with body temperature.
H2: The developed data model can accurately and meaningfully predict the relationship between the characteristics, medical history, and interventions affecting body temperature in preterm newborns receiving respiratory support.
Detailed description
Because the systems of preterm infants are not functionally mature, deficiencies are seen in critical physiological processes such as respiration and thermoregulation. Since respiratory functions are not fully developed, increased respiratory effort can increase energy expenditure and metabolic load, making it difficult to regulate body temperature and facilitate postnatal adaptation.
Increased respiratory effort can create a metabolic load that may increase the risk of hypothermia in preterm infants. In preterm infants experiencing respiratory distress, energy consumption increases, while the energy reserves necessary to maintain body temperature may be depleted more rapidly. As a result, thermoregulation may not be maintained, and the risk of hypothermia may increase. Furthermore, factors that increase respiratory effort may elevate oxygen demand, leading to changes in blood circulation and disruption of thermoregulatory mechanisms.
Maintaining normothermia in newborns is critically important and is known to have a direct impact on survival. The World Health Organization recognizes maintaining normothermia as a fundamental and critical component of newborn care.
Studies have shown that respiratory support interventions and care methods aimed at preventing hypothermia in preterm newborns reduce respiratory workload and help maintain more stable body temperature. Furthermore, the effects of non-invasive ventilation and nasal continuous positive airway pressure on body temperature in preterm infants requiring respiratory support have been examined, and it has been emphasized that the results need to be thoroughly evaluated in terms of thermoregulation.
In this context, our study aims to examine the relationship between body temperature and the characteristics, medical history, interventions performed within the first six hours, and follow-up findings of preterm newborns receiving respiratory support. By evaluating the relationships between variables in preterm infants receiving different types of respiratory support, a fundamental data model will be created that will contribute to optimizing practices aimed at maintaining thermoregulation. The results obtained may guide clinical practice by contributing to the development of appropriate thermoregulation management strategies in neonatal intensive care units, thereby reducing the risk of hypothermia.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infant | – | –Preterm infants born before 38 weeks of gestation who were immediately admitted to the neonatal intensive care unit after birth and received respiratory support. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm newborns hospitalized in the Neonatal Intensive Care Unit at Acıbadem Healthcare Group Hospitals in Istanbul
Key inclusion criteria (2 listed)
- Preterm newborns born before 38 weeks of gestation and immediately admitted to the neonatal intensive care unit after birth
- who received respiratory support
Key exclusion criteria (4 listed)
- Newborns who did not receive respiratory support immediately after birth despite being preterm at gestational age
- who have developmental health problems
- who have congenital health problems
- who were transferred from another healthcare facility after birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in body temperature
Time frame: At birth and every hour for up to 6 hours after birth
Body temperature measurement evaluated as axillary. Data for premature infants were collected hourly immediately after birth and for 6 hours following birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 36254265Getaneh FB, Misganaw NM, Mihretie DB, Bitew ZW. Admission Hypothermia and Factors Associated with Mortality among Admitted Hypothermic Preterm Neonates in Neonatal Intensive Care Units of Public Hospitals of Addis Ababa, Ethiopia. Int J Pediatr. 2022 Oct 8;2022:8078628. doi: 10.1155/2022/8078628. eCollection 2022.
- Background: PubMed 39033283Feyisa GT, Marami SN, Dinagde DD, Degefe BD, Abebe ST, Kitil GW, Biratu AK. Comparative study of neonatal hypothermia and associated factors among neonates in rural and urban areas of the Shebadino Woreda, Sidama region, Southern Ethiopia: a community-based comparative cross-sectional study. BMC Public Health. 2024 Jul 20;24(1):1945. doi: 10.1186/s12889-024-19504-8.
- Background: PubMed 33755686Nyandiko WM, Kiptoon P, Lubuya FA. Neonatal hypothermia and adherence to World Health Organisation thermal care guidelines among newborns at Moi Teaching and Referral Hospital, Kenya. PLoS One. 2021 Mar 23;16(3):e0248838. doi: 10.1371/journal.pone.0248838. eCollection 2021.
- Background: PubMed 34526138Mohamed SOO, Ahmed SMI, Khidir RJY, Shaheen MTHA, Adam MHM, Ibrahim BAY, Elmahdi EOA, Farah ASM. Outcomes of neonatal hypothermia among very low birth weight infants: a Meta-analysis. Matern Health Neonatol Perinatol. 2021 Sep 15;7(1):14. doi: 10.1186/s40748-021-00134-6.
- Background: PubMed 32974416Demtse AG, Pfister RE, Nigussie AK, McClure EM, Ferede YG, Tazu Bonger Z, Mekasha A, Demisse AG, Gidi NW, Metaferia G, Worku B, Goldenberg RL, Muhe LM. Hypothermia in Preterm Newborns: Impact on Survival. Glob Pediatr Health. 2020 Sep 13;7:2333794X20957655. doi: 10.1177/2333794X20957655. eCollection 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zehra Kan Öntürk, Assoc. Prof. principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature and Preterm, run by Acibadem University 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 2 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: finished, as of the sponsor's last update on 16 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body temperature (time frame: At birth and every hour for up to 6 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07176364, which also lists 5 linked publications.
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 16 Sep 2025.