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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05892809
Enrollment
91
Registered
2023-06-07
Start date
2018-03-01
Completion date
2019-01-01
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Disease, Nursing Caries

Keywords

term, preterm, vital signs, incubator cover

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).

Interventions

OTHERuse an incubator cover

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

Sponsors

Maltepe University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

A Pretest-Posttest Repeated Measures Design

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 42 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement and monitoring of newborn's pulse rateThe change in the newborn's heart rate within 30 minutes was monitored and measured.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 rateThe change in the newborn's respiratory rate within 30 minutes was monitored and measured.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 saturationThe change in the newborn's oxygen saturation within 30 minutes was monitored and measured.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 temperatureThe change in the newborn's body temperature within 30 minutes was monitored and measured.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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026