İstanbul Bilgi University
Şişli, Istanbul, 34387, Turkey (Türkiye)
NCT Number: NCT07111611
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.
Looking for future studies?
Notify Me32 week–37 week
All sexes
Interventional
Not applicable
Şişli, Istanbul, 34387, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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
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.
Other names: Non-traumatic Suction Technique
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.
Time frame: During suctioning and 10 minutes post-procedure. SpO₂ measured by pulse oximetry.
To assess the impact of suction technique on oxygenation stability.
Time frame: During suctioning and 10 minutes post-procedure. Heart Rate measured using bedside monitor.
To compare the effect of suction methods on cardiovascular stability.
Time frame: During suctioning
To measure the behavioral reponse and comfort level of the infant during the procedure. Sedation Subscore: Range = -2 to +2, lower = deeper sedation
Istanbul Bilgi University
Other
Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants During Non-Invasive Ventilation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06455631
Female Urogenital Diseases and Pregnancy Complications, Infant ALL
Ataşehir, Istanbul, Turkey (Türkiye)
View Trial DetailsNCT05430100
Female Urogenital Diseases and Pregnancy Complications, Neurologic Manifestations
Ankara, Turkey (Türkiye)
View Trial DetailsNCT05077345
Female Urogenital Diseases and Pregnancy Complications, Neurologic Manifestations
Gaziantep, Turkey (Türkiye)
View Trial DetailsNCT04006743
Female Urogenital Diseases and Pregnancy Complications, Neurologic Manifestations
Antalya, Turkey (Türkiye)
View Trial Details