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

Nursing Caries Clinical Trial

Official title:

Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs: a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892809
• Other study ID #: MaltepeUniversity
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2023
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 1, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disease
• Nursing Caries

Intervention

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

Locations

Country	Name	City	State
Turkey	Siverek State Hospital	Sanliurfa	Siverek

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.