Clinical Trials Directory

Trials / Completed

CompletedNCT07176364

Body Temperature in Preterm Neonates: Creating a Data Model

Body Temperature Monitoring and Factors Affecting Body Temperature in Preterm Neonates Receiving Respiratory Support: Creating a Data Model

Status
Completed
Phase
Study type
Observational
Enrollment
300 (actual)
Sponsor
Acibadem University · Academic / Other
Sex
All
Age
1 Day – 28 Days
Healthy volunteers
Accepted

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. 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.

Conditions

Timeline

Start date
2025-04-14
Primary completion
2025-05-09
Completion
2025-05-09
First posted
2025-09-16
Last updated
2025-09-16

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07176364. Inclusion in this directory is not an endorsement.