Hypothermia, NewbornNCT06654479
The Effect of Nursing Interventions on Body Temperatures of Infants
An observational study of Hypothermia, Newborn, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Hypothermia, Newborn
- What is being tested?
- In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined.
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2022to 8 Feb 2024
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Katip Çelebi University
Izmir, Çi̇ğli̇, 35620
About this study
Official title: The Effect of Location and Duration of Nursing Interventions on Body Temperatures of Infants in the Neonatal Intensive Care Unit
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.
Read the detailed description
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. The researcher monitored the duration of the procedure with a chronometer at the beginning of the procedure. Body temperature, incubator temperature.
- Conditions
- Hypothermia, Newborn
- Being tested
- In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined.
- Keywords
- Nursing, Newborn, Hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature of newborns
Changes in body temperature of neonates during routine interventions by nurses
Measured: The study was completed in 17 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start3 Oct 2022
- Primary completion20 Dec 2023
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia, NewbornStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beste Ozguven Oztornaci, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654479
- Sponsor's protocol ID
- 22.09.2022/0380
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Location and Duration of Nursing Interventions on Body Temperatures of Infants in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06654479
- Acronym / sponsor ID
- 22.09.2022/0380
- Conditions
- Hypothermia, Newborn
- Keywords
- Nursing, Newborn, Hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 23 Oct 2024 (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.
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.
Detailed description
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. The researcher monitored the duration of the procedure with a chronometer at the beginning of the procedure. Body temperature, incubator temperature.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study included neonates treated in the neonatal intensive care unit. | – | Other: In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined.In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined.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. | Other | The study included neonates treated in the neonatal intensive care unit. |
Primary outcome
Body temperature of newborns
Time frame: The study was completed in 17 months.
Changes in body temperature of neonates during routine interventions by nurses
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 23 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypothermia, Newborn, run by Izmir Katip Celebi 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 4 inclusion and 6 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 23 Oct 2024. 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?
Body temperature of newborns (time frame: The study was completed in 17 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024.