NIRS Levels of Infants in Neonatal Intensive Care

February 22, 2022 updated by: Ezgi Ayvaz, Eskisehir Osmangazi University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Eskisehir, Turkey, 26000
        • Eskisehir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

40 premature newborns

Description

Inclusion Criteria:

  • Neonates younger than a gestational age of 37 weeks
  • Those monitored in an open or closed incubator

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
infants receiving nursing care
Behavioral: nursing care practices
To determine the effect of nursing care practices on Near Infrared Spectroscopy (NIRS) levels in premature babies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nursing practices
Time Frame: 24 hours
Change of nursing practices on Near Infrared Spectroscopy levels
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

April 26, 2019

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (ACTUAL)

February 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EsksehirOU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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