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NCT Number: NCT05892809

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

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).

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Key information

Conditions

Neonatal Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Nursing Caries Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siverek State Hospital

Sanliurfa, Siverek, 63600, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

use an incubator cover

Other

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

Primary outcomes

  1. Measurement and monitoring of newborn's pulse rate

    Time frame: The 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.

  2. Measurement and monitoring of newborn's respiratory rate

    Time frame: The 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.

  3. Measurement and monitoring of newborn's oxygen saturation

    Time frame: The 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.

  4. Measurement and monitoring of newborn's body temperature

    Time frame: The 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.

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 7, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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