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

NCT05892809 | Completed

• 1 other identifier: MaltepeUniversity
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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).

Conditions

Neonatal Disease; Nursing Caries

Keywords

term; preterm; vital signs; incubator cover

Outcome Measures

Primary Outcomes (4)

• 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.

  The change in the newborn's heart rate within 30 minutes was monitored and measured.

• 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.

  The change in the newborn's respiratory rate within 30 minutes was monitored and measured.

• 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.

  The change in the newborn's oxygen saturation within 30 minutes was monitored and measured.

• 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.

  The change in the newborn's body temperature within 30 minutes was monitored and measured.

Study Arms (1)

With incubator cover group and without incubator cover

OTHER

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

Other: use an incubator cover

Interventions

use an incubator cover OTHER

Vital signs of term and preterm newborns were measured separately and with and without an incubator cover.

With incubator cover group and without incubator cover

Eligibility Criteria

• Age: 24 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Having life-threatening health problems

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Siverek State Hospital

Sanliurfa, Siverek, 63600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases; Premature Birth

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kenan Çetin, Nurse

  Neonatal Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Model Details: A Pretest-Posttest Repeated Measures Design

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: June 7, 2023
• Study Start: March 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)