Clinical trial NCT05892809: Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs
Official title: Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Disease
Nursing Caries
Keywords: term
preterm
vital signs
incubator cover
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 91
Sex: ALL
Minimum age (years): 24
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Pretest-Posttest Repeated Measures Design
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Measurement and monitoring of newborn's pulse rate
timeFrame: The change in the newborn's heart rate within 30 minutes was monitored and measured.
measure: Measurement and monitoring of newborn's respiratory rate
timeFrame: The change in the newborn's respiratory rate within 30 minutes was monitored and measured.
measure: Measurement and monitoring of newborn's oxygen saturation
timeFrame: The change in the newborn's oxygen saturation within 30 minutes was monitored and measured.
measure: Measurement and monitoring of newborn's body temperature
timeFrame: The change in the newborn's body temperature within 30 minutes was monitored and measured.
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Siverek State Hospital
state: Siverek
Study officials:
affiliation: Neonatal Intensive Care Unit
name: Kenan Çetin, Nurse
role: PRINCIPAL_INVESTIGATOR
References: