Body Temperature in Preterm Neonates: Creating a Data Model

September 9, 2025 updated by: Zehra Kan Onturk, Acibadem University

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ataşehir
      • Istanbul, Ataşehir, Turkey (Türkiye), 34750
        • Acıbadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Preterm newborns hospitalized in the Neonatal Intensive Care Unit at Acıbadem Healthcare Group Hospitals in Istanbul

Description

Inclusion Criteria:

  • Preterm newborns born before 38 weeks of gestation and immediately admitted to the neonatal intensive care unit after birth
  • who received respiratory support

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At birth and every hour for up to 6 hours after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Zehra Kan Öntürk, Assoc. Prof., Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2025

Primary Completion (Actual)

May 9, 2025

Study Completion (Actual)

May 9, 2025

Study Registration Dates

First Submitted

September 9, 2025

First Submitted That Met QC Criteria

September 9, 2025

First Posted (Estimated)

September 16, 2025

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2025/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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