PretermNCT07111611
Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants
A study testing Non-Traumatic Nasopharyngeal Suction Procedure in people with Preterm, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
Background: Non-invasive ventilation (NIV) in preterm infants often leads to secretion-related airway obstructions, requiring suctioning. Traditional oro/nasopharyngeal suction techniques may cause mucosal trauma, pain, and physiological instability. Read more about this study
- Who is it for?
- Ages 32 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm
- What is being tested?
- Non-Traumatic Nasopharyngeal Suction Procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jan 2020
- 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 32 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age between 32 0/6 and 36 6/7 weeks
- Receiving non-invasive ventilation (NIV) via nasal CPAP
- Clinically stable prior to suctioning
- Parental or legal guardian informed consent obtained
- Age within first 7 days of life at time of first suction procedure
Who cannot join
- Major congenital anomalies (e.g., craniofacial malformations, cardiac defects)
- Suspected or confirmed neurological disorders (e.g., intraventricular hemorrhage Grade III/IV)
- Presence of upper airway obstruction or nasal anomalies
- Infants requiring invasive mechanical ventilation at the time of study
- Any condition requiring continuous sedation or analgesia
- Hemodynamically unstable infants (e.g., hypotension requiring inotropes)
- Parental refusal or withdrawal of consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Bilgi University
Şişli, Istanbul, 34387
About this study
Official title: Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants During Non-Invasive Ventilation
Background: Non-invasive ventilation (NIV) in preterm infants often leads to secretion-related airway obstructions, requiring suctioning. Traditional oro/nasopharyngeal suction techniques may cause mucosal trauma, pain, and physiological instability.
Objective: To evaluate the effects of a novel non-traumatic oro/nasopharyngeal suction technique on physiological and behavioral parameters in preterm infants receiving NIV.
Methods: A randomized controlled trial was conducted with 100 preterm infants (32 0/6 - 36 6/7 weeks gestation) admitted to a Level IV NICU. Infants were randomized into intervention (non-traumatic suction) and control (routine suction) groups. Data on heart rate, respiratory rate, SpO₂, skin color, and pain/sedation scores (N-PASS) were collected before, during, and after suctioning.
Read the detailed description
This randomized controlled clinical trial was conducted to evaluate the effectiveness of a newly developed non-traumatic oro/nasopharyngeal suction technique in preterm infants receiving non-invasive ventilation (NIV). Traditional suction methods used to remove airway secretions in neonates are often associated with complications such as mucosal trauma, bradycardia, hypoxia, and increased pain.
The non-traumatic technique involves administering a small volume of sterile saline through one nostril and using gentle suction from the other nostril or the mouth without direct mucosal contact. This approach is designed to minimize trauma and discomfort.
A total of 100 preterm infants with gestational ages between 32 0/6 and 36 6/7 weeks were included and randomized into two groups: an intervention group receiving the non-traumatic suction method and a control group undergoing standard suction. Key outcome measures included physiological parameters (heart rate, respiratory rate, SpO₂, skin color) and behavioral indicators assessed using the Neonatal Pain, Agitation, and Sedation Scale (N-PASS). Data were collected before, during, and after suctioning procedures.
- Conditions
- Preterm
- Being tested
- Non-Traumatic Nasopharyngeal Suction Procedure
- Keywords
- non-invasive ventilation, preterm infant, suction, pain, physological parameters
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Traumatic Nasopharyngeal Suction ProcedureProcedure or surgery
Also called Non-traumatic Suction Technique
A modified suctioning technique that avoids deep catheter insertion and minimizes mucosal contact. Sterile saline (0.9%) is instilled into one nostril, and secretions are aspirated using external suction via the opposite nostril or mouth. This approach is designed to reduce pain and physiological stress compared to standard suction methods in preterm infants undergoing non-invasive ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Non-Traumatic Suction Group | Experimental | Infants in this group underwent a non-traumatic oro/nasopharyngeal suction procedure. A 10 Fr suction catheter with a blunt-cut tip and a 10 ml syringe were used. Depending on secretion amount and thickness, 5-10 ml of 0.9% saline was rapidly instilled through one nostril. Secretions were then aspirated using 150-200 mmHg negative pressure via the opposite nostril and the mouth, without deep catheter insertion.
Physiological parameters (heart rate, respiratory rate, oxygen saturation, skin color) and behavioral responses (N-PASS pain and sedation scores) were recorded before, during, and 10 minutes after the procedure.opposite nostril and the mouth, without deep catheter insertion. The procedure was carefully performed without mucosal contact to prevent trauma and bleeding. The entire aspiration process lasted 5-10 seconds. Physiological parameters and behavioral responses (N-PASS scores) were recorded before, during, and 10 minutes after the procedure. Receives: Procedure: Non-Traumatic Nasopharyngeal Suction Procedure |
| Standard Suction Group | No intervention | Infants in this group received routine oro/nasopharyngeal suctioning as performed in standard clinical practice. A 6-8 Fr suction catheter was used without prior saline instillation. The catheter was inserted through the mouth and/or nostrils into the nasopharynx, and secretions were aspirated using 60-100 mmHg negative pressure. The suction procedure lasted 5-10 seconds. The same physiological and behavioral parameters were monitored and recorded before, during, and after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score During Suctioning, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) pain subscore
To evaluate and compare the level of pain experienced by preterm infants during suctioning using either the non-traumatic or standard technique. Pain Subscore: Range = 0 to 10, higher score = more pain.
Measured: During suctioning (within 1 minute of procedure start)
Secondary outcomes (3)
Change in Oxygen Saturation (SpO₂) During and After Suctioning
To assess the impact of suction technique on oxygenation stability.
Measured: During suctioning and 10 minutes post-procedure. SpO₂ measured by pulse oximetry.
Change in Heart Rate (HR) During and After Suctioning
To compare the effect of suction methods on cardiovascular stability.
Measured: During suctioning and 10 minutes post-procedure. Heart Rate measured using bedside monitor.
Change in Sedation Score During Suctioning,N-PASS sedation subscore,
To measure the behavioral reponse and comfort level of the infant during the procedure. Sedation Subscore: Range = -2 to +2, lower = deeper sedation
Measured: During suctioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PretermStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Parallel Assignment Randomized Controlled two groups (control group and study group)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru temizsoy, Istanbul Bilgi University
- Investigators
- Ebru Temizsoy, PhD,RN, Principal investigator, İstanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111611
- Sponsor's protocol ID
- 159
- Status last verified
- Aug 2025
- First submitted
- 25 May 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Temizsoy E, Topcuoglu S, Aliustaoglu H, Ozkan E, Karatekin G. Effects of a less invasive suction protocol on pain and physiological stability in preterm infants receiving non-invasive ventilation: a randomized controlled trial. BMC Pediatr. 2026 Jun 26. doi: 10.1186/s12887-026-07212-8. Online ahead of print.
PubMed 42363180
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants During Non-Invasive Ventilation
- ClinicalTrials.gov ID
- NCT07111611
- Acronym / sponsor ID
- 159
- Conditions
- Preterm
- Keywords
- non-invasive ventilation, preterm infant, suction, pain, physological parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 8 Aug 2025 (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.
Background: Non-invasive ventilation (NIV) in preterm infants often leads to secretion-related airway obstructions, requiring suctioning. Traditional oro/nasopharyngeal suction techniques may cause mucosal trauma, pain, and physiological instability.
Objective: To evaluate the effects of a novel non-traumatic oro/nasopharyngeal suction technique on physiological and behavioral parameters in preterm infants receiving NIV.
Methods: A randomized controlled trial was conducted with 100 preterm infants (32 0/6 - 36 6/7 weeks gestation) admitted to a Level IV NICU. Infants were randomized into intervention (non-traumatic suction) and control (routine suction) groups. Data on heart rate, respiratory rate, SpO₂, skin color, and pain/sedation scores (N-PASS) were collected before, during, and after suctioning.
Detailed description
This randomized controlled clinical trial was conducted to evaluate the effectiveness of a newly developed non-traumatic oro/nasopharyngeal suction technique in preterm infants receiving non-invasive ventilation (NIV). Traditional suction methods used to remove airway secretions in neonates are often associated with complications such as mucosal trauma, bradycardia, hypoxia, and increased pain.
The non-traumatic technique involves administering a small volume of sterile saline through one nostril and using gentle suction from the other nostril or the mouth without direct mucosal contact. This approach is designed to minimize trauma and discomfort.
A total of 100 preterm infants with gestational ages between 32 0/6 and 36 6/7 weeks were included and randomized into two groups: an intervention group receiving the non-traumatic suction method and a control group undergoing standard suction. Key outcome measures included physiological parameters (heart rate, respiratory rate, SpO₂, skin color) and behavioral indicators assessed using the Neonatal Pain, Agitation, and Sedation Scale (N-PASS). Data were collected before, during, and after suctioning procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomized Controlled two groups (control group and study group)
| Arm | Type | Receives |
|---|---|---|
| Non-Traumatic Suction Group | Experimental | Procedure: Non-Traumatic Nasopharyngeal Suction ProcedureInfants in this group underwent a non-traumatic oro/nasopharyngeal suction procedure. A 10 Fr suction catheter with a blunt-cut tip and a 10 ml syringe were used. Depending on secretion amount and thickness, 5-10 ml of 0.9% saline was rapidly instilled through one nostril. Secretions were then aspirated using 150-200 mmHg negative pressure via the opposite nostril and the mouth, without deep catheter insertion. Physiological parameters (heart rate, respiratory rate, oxygen saturation, skin color) and behavioral responses (N-PASS pain and sedation scores) were recorded before, during, and 10 minutes after the procedure.opposite nostril and the mouth, without deep catheter insertion. The procedure was carefully performed without mucosal contact to prevent trauma and bleeding. The entire aspiration process lasted 5-10 seconds. Physiological parameters and behavioral responses (N-PASS scores) were recorded before, during, and 10 minutes after the procedure. |
| Standard Suction Group | No intervention | –Infants in this group received routine oro/nasopharyngeal suctioning as performed in standard clinical practice. A 6-8 Fr suction catheter was used without prior saline instillation. The catheter was inserted through the mouth and/or nostrils into the nasopharynx, and secretions were aspirated using 60-100 mmHg negative pressure. The suction procedure lasted 5-10 seconds. The same physiological and behavioral parameters were monitored and recorded before, during, and after the procedure. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age between 32 0/6 and 36 6/7 weeks
- Receiving non-invasive ventilation (NIV) via nasal CPAP
- Clinically stable prior to suctioning
- Parental or legal guardian informed consent obtained
- Age within first 7 days of life at time of first suction procedure
Key exclusion criteria (7 listed)
- Major congenital anomalies (e.g., craniofacial malformations, cardiac defects)
- Suspected or confirmed neurological disorders (e.g., intraventricular hemorrhage Grade III/IV)
- Presence of upper airway obstruction or nasal anomalies
- Infants requiring invasive mechanical ventilation at the time of study
- Any condition requiring continuous sedation or analgesia
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 |
|---|---|---|
| Non-Traumatic Nasopharyngeal Suction ProcedureAlso: Non-traumatic Suction TechniqueA modified suctioning technique that avoids deep catheter insertion and minimizes mucosal contact. Sterile saline (0.9%) is instilled into one nostril, and secretions are aspirated using external suction via the opposite nostril or mouth. This approach is designed to reduce pain and physiological stress compared to standard suction methods in preterm infants undergoing non-invasive ventilation. | Procedure or surgery | Non-Traumatic Suction Group |
Primary outcome
Change in Pain Score During Suctioning, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) pain subscore
Time frame: During suctioning (within 1 minute of procedure start)
To evaluate and compare the level of pain experienced by preterm infants during suctioning using either the non-traumatic or standard technique. Pain Subscore: Range = 0 to 10, higher score = more pain.
3 secondary outcomes
Change in Oxygen Saturation (SpO₂) During and After Suctioning
Time frame: During suctioning and 10 minutes post-procedure. SpO₂ measured by pulse oximetry.
Change in Heart Rate (HR) During and After Suctioning
Time frame: During suctioning and 10 minutes post-procedure. Heart Rate measured using bedside monitor.
Change in Sedation Score During Suctioning,N-PASS sedation subscore,
Time frame: During suctioning
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 8 Aug 2025.
- Derived from this study: PubMed 42363180Temizsoy E, Topcuoglu S, Aliustaoglu H, Ozkan E, Karatekin G. Effects of a less invasive suction protocol on pain and physiological stability in preterm infants receiving non-invasive ventilation: a randomized controlled trial. BMC Pediatr. 2026 Jun 26. doi: 10.1186/s12887-026-07212-8. Online ahead of print.
- 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.
Ebru Temizsoy, PhD,RN principal investigator
İstanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Traumatic Nasopharyngeal Suction Procedure in people with Preterm, run by Istanbul Bilgi 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 7 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 8 Aug 2025. 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?
Change in Pain Score During Suctioning, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) pain subscore (time frame: During suctioning (within 1 minute of procedure start)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07111611, which also lists 1 linked publication.
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 8 Aug 2025.