NCT06654479

Brief Summary

Aim: This study planned the intervention and care of term and preterm newborns treated in neonatal intensive care units, including thermoregulation, procedure duration and care with the opening technique of incubator covers. Method: This non-participatory observational study was conducted between October 2022 and December 2023 with a total of 104 term and preterm newborns who were being treated in the Neonatal Intensive Care Unit of S.B.U. Dr. Behçet Uz Children's Diseases and Surgery Training and Research Hospital, Izmir, Turkey. In the study, the Case Report Form prepared by the researcher and based on the research method, dependent/independent variables and inclusion/exclusion criteria was used to collect data. The opening techniques of incubator lids were determined as double intervention window open, single intervention window open and incubator lid fully open. After selected newborns who met the inclusion/exclusion criteria, standardisation was ensured by explaining to the nurse who would provide care and intervention the location of the heat probe (right abdominal region) and that the patient should be in the supine position. The incubator temperature, incubator humidity, body temperature and neonatal intensive care room temperature and humidity before the procedure, the technique of opening the incubator lid during the care delivery phase and the intervention applied were recorded on the Case Report Form.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

October 20, 2024

Last Update Submit

October 22, 2024

Conditions

Keywords

NursingNewbornHypothermia

Outcome Measures

Primary Outcomes (1)

  • Body temperature of newborns

    Changes in body temperature of neonates during routine interventions by nurses

    The study was completed in 17 months.

Study Arms (1)

The study included neonates treated in the neonatal intensive care unit.

In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined.

Other: In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined.

Interventions

The study is an observational study. The newborns were not intervened by the researcher. Body temperature changes were observed during routine practices of nurses in the clinic.

The study included neonates treated in the neonatal intensive care unit.

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 104 newborns cared for by 72 nurses who consented to participate in the study and who met the inclusion criteria were included in the sample. No case was lost at the end of the study. The power level of the sample was found to be 0.878.

You may qualify if:

  • In the neonatal intensive care unit,
  • History of mature and premature birth (≤37 GH),
  • Definitive diagnosis known,
  • Newborns treated in a single brand of incubator, as different brands of incubators may vary in opening the lids and heating the incubators according to the characteristics of the incubator.

You may not qualify if:

  • Diagnosed with asphyxia and receiving therapeutic cooling treatment,
  • Within 10 days postoperatively,
  • Active fever or a diagnosis of sepsis,
  • Intervened under the radiant heater,
  • Clinical condition deteriorated during the study period,
  • Newborns who are followed and clothed to be placed with their mother.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Katip Çelebi University

Izmir, Çi̇ğli̇, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

October 20, 2024

First Posted

October 23, 2024

Study Start

October 3, 2022

Primary Completion

December 20, 2023

Study Completion

February 8, 2024

Last Updated

October 23, 2024

Record last verified: 2024-10

Locations