NCT05246150

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

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

March 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

January 27, 2022

Last Update Submit

February 22, 2022

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

  • nursing practices

    Change of nursing practices on Near Infrared Spectroscopy levels

    24 hours

Study Arms (1)

infants receiving nursing care

Behavioral: nursing care practices

Interventions

nursing care practicesBEHAVIORAL

To determine the effect of nursing care practices on Near Infrared Spectroscopy (NIRS) levels in premature babies

infants receiving nursing care

Eligibility Criteria

Age1 Day - 40 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

40 premature newborns

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir

Eskişehir, 26000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NURSE

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 18, 2022

Study Start

March 1, 2019

Primary Completion

April 1, 2019

Study Completion

April 26, 2019

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations

TU(1)