Premature BirthNCT05246150
NIRS Levels of Infants in Neonatal Intensive Care
An observational study of Premature Birth, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted to determine the effect of nursing care practices on the Near Infrared Spectroscopy (NIRS) levels of premature infants in the neonatal intensive care unit (NICU). Materials and Method: This is a cross-sectional, analytical study. Read more about this study
- Who is it for?
- Ages 1 day to 40 daysHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- nursing care practices
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 26 Apr 2019
- How long will I take part?
- 1 Day
- 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 to 40 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: 40 premature newborns
Who may be able to join
- Neonates younger than a gestational age of 37 weeks
- Those monitored in an open or closed incubator
Who cannot join
- Intubated neonates connected to a mechanical ventilator
- Infants of a gestational age of 37 weeks or more
- Infants under sedation
- Infants with neurological illness (e.g., hypoxic ischemic encephalopathy, hydrocdphalus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Nursıng Practıces On The Near Infrared Spectroscopy Levels Of Premature Infants
Aim: This study was conducted to determine the effect of nursing care practices on the Near Infrared Spectroscopy (NIRS) levels of premature infants in the neonatal intensive care unit (NICU).
Materials and Method: This is a cross-sectional, analytical study. It was conducted over the period March 1 - April 26, 2019 in the Neonatal Intensive Care Unit (NICU) of Eskişehir Osmangazi University (ESOGU) Health Practices and Research Hospital. We did not calculate sample size, but included in the study, after the parents had been informed about the research, the entire universe of neonates in the NICU who matched the inclusion criteria during the period March 1 - April 26, 2019. The study was completed with 40 neonates. Data collection was performed with a "Descriptive Data Form," and a "Procedures Performed Chart." The data were evaluated with the IBM SPSS 24 package program.
- Conditions
- Premature Birth
- Being tested
- nursing care practices
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing care practicesBehavioural
To determine the effect of nursing care practices on Near Infrared Spectroscopy (NIRS) levels in premature babies
| Study group | Role | What they receive |
|---|---|---|
| infants receiving nursing care | Not described Receives: Behavioral: nursing care practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
nursing practices
Change of nursing practices on Near Infrared Spectroscopy levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Mar 2019
- Primary completion1 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Ayvaz, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246150
- Sponsor's protocol ID
- EsksehirOU
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 9 Mar 2022
- Results posted
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Nursıng Practıces On The Near Infrared Spectroscopy Levels Of Premature Infants
- ClinicalTrials.gov ID
- NCT05246150
- Acronym / sponsor ID
- EsksehirOU
- Conditions
- Premature Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 18 Feb 2022 (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 was conducted to determine the effect of nursing care practices on the Near Infrared Spectroscopy (NIRS) levels of premature infants in the neonatal intensive care unit (NICU).
Materials and Method: This is a cross-sectional, analytical study. It was conducted over the period March 1 - April 26, 2019 in the Neonatal Intensive Care Unit (NICU) of Eskişehir Osmangazi University (ESOGU) Health Practices and Research Hospital. We did not calculate sample size, but included in the study, after the parents had been informed about the research, the entire universe of neonates in the NICU who matched the inclusion criteria during the period March 1 - April 26, 2019. The study was completed with 40 neonates. Data collection was performed with a "Descriptive Data Form," and a "Procedures Performed Chart." The data were evaluated with the IBM SPSS 24 package program.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infants receiving nursing care | – | Behavioral: nursing care practices |
Who may qualify
- Ages
- 1 day to 40 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 40 premature newborns
Key inclusion criteria (2 listed)
- Neonates younger than a gestational age of 37 weeks
- Those monitored in an open or closed incubator
Key exclusion criteria (4 listed)
- Intubated neonates connected to a mechanical ventilator
- Infants of a gestational age of 37 weeks or more
- Infants under sedation
- Infants with neurological illness (e.g., hypoxic ischemic encephalopathy, hydrocdphalus)
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 |
|---|---|---|
| nursing care practicesTo determine the effect of nursing care practices on Near Infrared Spectroscopy (NIRS) levels in premature babies | Behavioural | infants receiving nursing care |
Primary outcome
nursing practices
Time frame: 24 hours
Change of nursing practices on Near Infrared Spectroscopy levels
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 9 Mar 2022.
- 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 Premature Birth, run by Eskisehir Osmangazi 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 2 inclusion and 4 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 9 Mar 2022. 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?
nursing practices (time frame: 24 hours). 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 9 Mar 2022.