NewbornNCT06435572
Comparison of Open and Closed Aspiration in Newborns
A study testing Suction in people with Newborn, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Endotracheal aspiration is a necessary procedure performed by nurses in neonatal intensive care units to increase oxygenation and remove secretions from the airways. It is one of the painful procedures that most frequently causes stress in intubated newborns. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Newborn
- What is being tested?
- Suction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2024to 21 Dec 2025
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newborns monitored with mechanical ventilation
- Newborn who need suctioning,
- Newborn who did not undergo painful procedures one hour before aspiration.
- Hemodynamically stable newborn;
Who cannot join
- Newborn with any facial/skull deformities
- Newborn with chromosomal/genetic abnormalities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aslı Alaca
Buca, İ̇zmi̇r- Turkey
ASLI ALACA, 05062741676, alaca_asli_1992@hotmail.com
alaca_asli_1992@hotmail.com
About this study
Official title: Effect of Open and Closed Suction Systems on Newborn's Pain and Vital Signs in Neonatal Intensive Care
Endotracheal aspiration is a necessary procedure performed by nurses in neonatal intensive care units to increase oxygenation and remove secretions from the airways. It is one of the painful procedures that most frequently causes stress in intubated newborns.
Read the detailed description
The aim of this study is to examine the effect of open and closed system suction, which is one of the invasive procedures frequently applied in neonatal intensive care, on the baby's pain and vital signs. There is a need for innovative, evidence-based practices to be implemented by nurses in clinics to minimize complications related to endotracheal suction.
- Conditions
- Newborn
- Being tested
- Suction
- Keywords
- Closed system suctioning, Open system suctioning, Pain, Neonatal intensive care, Newborn, Suction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuctionOther
Also called open suction, closed suction
Each patient will be evaluated as both the experimental and control group. In the study, open suction applied to the patient will be evaluated as control, and closed suction will be considered as the experimental group. The first suction of the same patient during the day will be done as open suction, and the second suction will be done as closed suction.
| Study group | Role | What they receive |
|---|---|---|
| Experimental and A control group | Experimental | Each patient will be evaluated as both the experimental and control group. In line with the patient's aspiration needs, two different suction methods will be applied and the effects of the methods will be evaluated on the same patient. In the study, open suction applied to the patient will be considered as the control group, and closed suction will be considered as the experimental group. The first suction of the same patient during the day will be performed as open suction, and the second suction will be performed as closed suction. Pain and physiological parameters will be evaluated before, during and 30 minutes after each sucking session. Receives: Other: Suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
differences in pain between open and closed suctioning systems
Measured: Pain will be evaluated before, during and 30 minutes after each suction procedure.
Oxygen saturation
differences in oxygen saturation between open and closed suctioning systems
Measured: Oxygen saturation will be evaluated before, during and 30 minutes after each suction procedure
Heart rate
differences in heart rate between open and closed suctioning systems
Measured: Heart rate will be evaluated before, during and 30 minutes after each aspiration procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start21 Jun 2024 (estimated)
- Primary completion21 Jun 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient will be considered as both an experimental and a control group.Two different aspiration methods will be applied in line with the patient's aspiration needs, and the effect of the methods will be evaluated on the same patient. In the study, open aspiration applied to the patient will be evaluated as control, and closed aspiration will be considered as the experimental group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Alaca, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435572
- Sponsor's protocol ID
- aslialaca
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Open and Closed Suction Systems on Newborn's Pain and Vital Signs in Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT06435572
- Acronym / sponsor ID
- aslialaca
- Conditions
- Newborn
- Keywords
- Closed system suctioning, Open system suctioning, Pain, Neonatal intensive care, Newborn, Suction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 21 Jun 2024 (estimated)
- Primary completion
- 21 Jun 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 30 May 2024 (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.
Endotracheal aspiration is a necessary procedure performed by nurses in neonatal intensive care units to increase oxygenation and remove secretions from the airways. It is one of the painful procedures that most frequently causes stress in intubated newborns.
Detailed description
The aim of this study is to examine the effect of open and closed system suction, which is one of the invasive procedures frequently applied in neonatal intensive care, on the baby's pain and vital signs. There is a need for innovative, evidence-based practices to be implemented by nurses in clinics to minimize complications related to endotracheal suction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient will be considered as both an experimental and a control group.Two different aspiration methods will be applied in line with the patient's aspiration needs, and the effect of the methods will be evaluated on the same patient. In the study, open aspiration applied to the patient will be evaluated as control, and closed aspiration will be considered as the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Experimental and A control group | Experimental | Other: SuctionEach patient will be evaluated as both the experimental and control group. In line with the patient's aspiration needs, two different suction methods will be applied and the effects of the methods will be evaluated on the same patient. In the study, open suction applied to the patient will be considered as the control group, and closed suction will be considered as the experimental group. The first suction of the same patient during the day will be performed as open suction, and the second suction will be performed as closed suction. Pain and physiological parameters will be evaluated before, during and 30 minutes after each sucking session. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Newborns monitored with mechanical ventilation
- Newborn who need suctioning,
- Newborn who did not undergo painful procedures one hour before aspiration.
- Hemodynamically stable newborn;
Key exclusion criteria (2 listed)
- Newborn with any facial/skull deformities
- Newborn with chromosomal/genetic abnormalities
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 |
|---|---|---|
| SuctionAlso: open suction, closed suctionEach patient will be evaluated as both the experimental and control group. In the study, open suction applied to the patient will be evaluated as control, and closed suction will be considered as the experimental group. The first suction of the same patient during the day will be done as open suction, and the second suction will be done as closed suction. | Other | Experimental and A control group |
Primary outcome
Pain score
Time frame: Pain will be evaluated before, during and 30 minutes after each suction procedure.
differences in pain between open and closed suctioning systems
Oxygen saturation
Time frame: Oxygen saturation will be evaluated before, during and 30 minutes after each suction procedure
differences in oxygen saturation between open and closed suctioning systems
Heart rate
Time frame: Heart rate will be evaluated before, during and 30 minutes after each aspiration procedure
differences in heart rate between open and closed suctioning systems
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suction in people with Newborn, run by Izmir Katip Celebi 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ASLI ALACA, MSc (05062741676, alaca_asli_1992@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Pain will be evaluated before, during and 30 minutes after each suction procedure.). The study lists 3 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 30 May 2024.