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

Sponsor
Maltepe University (Other)
Overall Status
Completed
CT.gov ID
NCT05892809
Collaborator
(none)
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Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: use an incubator cover
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
91 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A Pretest-Posttest Repeated Measures DesignA Pretest-Posttest Repeated Measures Design
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs: a Prospective Randomized Study
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: With incubator cover group and without incubator cover

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

Outcome Measures

Primary Outcome Measures

  1. Measurement and monitoring of newborn's pulse rate [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Weeks to 42 Weeks
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Siverek State Hospital Şanlıurfa Siverek Turkey 63600

Sponsors and Collaborators

  • Maltepe University

Investigators

  • Principal Investigator: Kenan Çetin, Nurse, Neonatal Intensive Care Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Behice Ekici, Assistant Professor, PhD, Maltepe University
ClinicalTrials.gov Identifier:
NCT05892809
Other Study ID Numbers:
  • MaltepeUniversity
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Behice Ekici, Assistant Professor, PhD, Maltepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2023