Body Temperature in Preterm Neonates: Creating a Data Model

NCT07176364 | Completed

• 1 other identifier: ATADEK-2025/05
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temperature; Preterm

Keywords

PRETERM; TEMPERATURE; INFANT; DECISION TREE; VENTILATION

Outcome Measures

Primary Outcomes (1)

• 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.

  At birth and every hour for up to 6 hours after birth

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 36254265 BACKGROUND

• Feyisa 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.

  PMID: 39033283 BACKGROUND

• Nyandiko 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.

  PMID: 33755686 BACKGROUND

• Mohamed 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.

  PMID: 34526138 BACKGROUND

• Demtse 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.

  PMID: 32974416 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zehra Kan Öntürk, Assoc. Prof.

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: April 14, 2025
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)