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Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs

Primary Purpose

Neonatal Disease, Nursing Caries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
use an incubator cover
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Disease focused on measuring term, preterm, vital signs, incubator cover

Eligibility Criteria

24 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Parents giving verbal and written consent, Hospitalized in the II. Level NICU Those born at 38-42 weeks of gestation Those born at 24-38 weeks of gestation Newborns with a body weight of 1500-2500 grams Exclusion Criteria: Having life-threatening health problems

Sites / Locations

  • Siverek State Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

With incubator cover group and without incubator cover

Arm Description

The incubator cover was covered while the neonate was lying in the incubator. Vital signs were measured at 0th, 15th, and 30th minutes.

Outcomes

Primary Outcome Measures

Measurement and monitoring of newborn's pulse rate
Physiological parameters of newborns will be evaluated. Multi-parameter monitor will be used for pulse rate, The newborn's heart rate per minute was measured. Vital signs of term and preterm will be measured without and with incubator cover. Vital signs of newborns will be measured three times. These measurements will be made at 0th, 15th, and 30th minutes. The medians of the measurement results will be taken and interpreted according to the reference range of the physiological measurement parameters.
Measurement and monitoring of newborn's respiratory rate
Physiological parameters of newborns will be evaluated. Multi-parameter monitor will be used for respiratory rate, The respiratory rate of the newborn per minute was measured. Vital signs of term and preterm will be measured without and with incubator cover. Vital signs of newborns will be measured three times. These measurements will be made at 0th, 15th, and 30th minutes. The medians of the measurement results will be taken and interpreted according to the reference range of the physiological measurement parameters.
Measurement and monitoring of newborn's oxygen saturation
Physiological parameters of newborns will be evaluated. Multi-parameter monitor will be used for oxygen saturation, The oxygen saturation of the newborn was measured. Oxygen saturation will be evaluated in %. Vital signs of term and preterm will be measured without and with incubator cover. Vital signs of newborns will be measured three times. These measurements will be made at 0th, 15th, and 30th minutes.The medians of the measurement results will be taken and interpreted according to the reference range of the physiological measurement parameters.
Measurement and monitoring of newborn's body temperature
Physiological parameters of newborns will be evaluated. Multi-parameter monitor will be used for oxygen saturation, The body temperature of the newborn was measured. Body temperature will be evaluated in degrees Celsius. Vital signs of term and preterm will be measured without and with incubator cover. Vital signs of newborns will be measured three times. These measurements will be made at 0th, 15th, and 30th minutes. The medians of the measurement results will be taken and interpreted according to the reference range of the physiological measurement parameters.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2023
Last Updated
May 28, 2023
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05892809
Brief Title
Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs
Official Title
Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit. Methods: 91 neonates presenting to a neonatal intensive care unit who met the inclusion criteria were included in the study. Vital signs of neonates were measured with and without incubator cover. Measurements were performed three times (0th, 15th, and 30th minute).
Detailed Description
Term and preterm are exposed to many stimuli during their stay in the neonatal intensive care unite (NICU). These stimuli; operation and alarm sounds of devices, continuous and high level ambient lighting. These stimuli can cause deviations in the physiological indicators of newborns, and hearing and vision loss. The aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit. Methods: This study is a prospective repeated measure pretest-posttest repeated-measures design. 91 term and preterm newborns who were hospitalized in the neonatal intensive care unit and met the inclusion criteria were included in this study. Neonates were admitted to the study if they satisfied all of the following criteria: (1) term and preterms, (2) admitted to NICU, (3) clinically stable, (4) verbal and written consent from the parent. Term and preterm neonates were randomized into two groups (term group = 44, and preterm group = 47 neonates). Vital signs of both groups were measured with and without incubator cover. Measurements were performed three times (0th, 15th, and 30th minute).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Disease, Nursing Caries
Keywords
term, preterm, vital signs, incubator cover

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A Pretest-Posttest Repeated Measures Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With incubator cover group and without incubator cover
Arm Type
Other
Arm Description
The incubator cover was covered while the neonate was lying in the incubator. Vital signs were measured at 0th, 15th, and 30th minutes.
Intervention Type
Other
Intervention Name(s)
use an incubator cover
Intervention Description
Vital signs of term and preterm newborns were measured separately and with and without an incubator cover.
Primary Outcome Measure Information:
Title
Measurement and monitoring of newborn's pulse rate
Description
Physiological parameters of newborns will be evaluated. Multi-parameter monitor will be used for pulse rate, The newborn's heart rate per minute was measured. Vital signs of term and preterm will be measured without and with incubator cover. Vital signs of newborns will be measured three times. These measurements will be made at 0th, 15th, and 30th minutes. The medians of the measurement results will be taken and interpreted according to the reference range of the physiological measurement parameters.
Time Frame
The change in the newborn's heart rate within 30 minutes was monitored and measured.
Title
Measurement and monitoring of newborn's respiratory rate
Description
Physiological parameters of newborns will be evaluated. Multi-parameter monitor will be used for respiratory rate, The respiratory rate of the newborn per minute was measured. Vital signs of term and preterm will be measured without and with incubator cover. Vital signs of newborns will be measured three times. These measurements will be made at 0th, 15th, and 30th minutes. The medians of the measurement results will be taken and interpreted according to the reference range of the physiological measurement parameters.
Time Frame
The change in the newborn's respiratory rate within 30 minutes was monitored and measured.
Title
Measurement and monitoring of newborn's oxygen saturation
Description
Physiological parameters of newborns will be evaluated. Multi-parameter monitor will be used for oxygen saturation, The oxygen saturation of the newborn was measured. Oxygen saturation will be evaluated in %. Vital signs of term and preterm will be measured without and with incubator cover. Vital signs of newborns will be measured three times. These measurements will be made at 0th, 15th, and 30th minutes.The medians of the measurement results will be taken and interpreted according to the reference range of the physiological measurement parameters.
Time Frame
The change in the newborn's oxygen saturation within 30 minutes was monitored and measured.
Title
Measurement and monitoring of newborn's body temperature
Description
Physiological parameters of newborns will be evaluated. Multi-parameter monitor will be used for oxygen saturation, The body temperature of the newborn was measured. Body temperature will be evaluated in degrees Celsius. Vital signs of term and preterm will be measured without and with incubator cover. Vital signs of newborns will be measured three times. These measurements will be made at 0th, 15th, and 30th minutes. The medians of the measurement results will be taken and interpreted according to the reference range of the physiological measurement parameters.
Time Frame
The change in the newborn's body temperature within 30 minutes was monitored and measured.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parents giving verbal and written consent, Hospitalized in the II. Level NICU Those born at 38-42 weeks of gestation Those born at 24-38 weeks of gestation Newborns with a body weight of 1500-2500 grams Exclusion Criteria: Having life-threatening health problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenan Çetin, Nurse
Organizational Affiliation
Neonatal Intensive Care Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siverek State Hospital
City
Şanlıurfa
State/Province
Siverek
ZIP/Postal Code
63600
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs

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