Neonatal DiseaseNCT05892809
Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs
A study testing use an incubator cover in people with Neonatal Disease and Nursing Caries, run by Maltepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 24 to 42 weeks
- Conditions the study is for
- Neonatal Disease, Nursing Caries
- What is being tested?
- use an incubator cover
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Having life-threatening health problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Siverek State Hospital
Sanliurfa, Siverek, 63600
About this study
Official title: Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs: a Prospective Randomized Study
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).
Read the 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).
- Conditions
- Neonatal Disease, Nursing Caries
- Being tested
- use an incubator cover
- Keywords
- term, preterm, vital signs, incubator cover
- Medical subject headings
- Infant, Newborn, Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use an incubator coverOther
Vital signs of term and preterm newborns were measured separately and with and without an incubator cover.
| Study group | Role | What they receive |
|---|---|---|
| With incubator cover group and without incubator cover | Other | The incubator cover was covered while the neonate was lying in the incubator. Vital signs were measured at 0th, 15th, and 30th minutes. Receives: Other: use an incubator cover |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The change in the newborn's heart rate within 30 minutes was monitored and measured.
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.
Measured: The change in the newborn's respiratory rate within 30 minutes was monitored and measured.
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.
Measured: The change in the newborn's oxygen saturation within 30 minutes was monitored and measured.
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.
Measured: The change in the newborn's body temperature within 30 minutes was monitored and measured.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Mar 2018
- Primary completion1 Jun 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Pretest-Posttest Repeated Measures Design
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Behice Ekici, Maltepe University
- Investigators
- Kenan Çetin, Nurse, Principal investigator, Neonatal Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892809
- Sponsor's protocol ID
- MaltepeUniversity
- Status last verified
- May 2023
- First submitted
- 30 Apr 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05892809
- Acronym / sponsor ID
- MaltepeUniversity
- Conditions
- Neonatal Disease, Nursing Caries
- Keywords
- term, preterm, vital signs, incubator cover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Pretest-Posttest Repeated Measures Design
| Arm | Type | Receives |
|---|---|---|
| With incubator cover group and without incubator cover | Other | Other: use an incubator coverThe incubator cover was covered while the neonate was lying in the incubator. Vital signs were measured at 0th, 15th, and 30th minutes. |
Who may qualify
- Ages
- 24 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Having life-threatening health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use an incubator coverVital signs of term and preterm newborns were measured separately and with and without an incubator cover. | Other | With incubator cover group and without incubator cover |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenan Çetin, Nurse principal investigator
Neonatal Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use an incubator cover in people with Neonatal Disease and Nursing Caries, run by Maltepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.