Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants

Not Applicable

Completed

• Conditions: Preterm

• Registration Number: NCT07111611
• Lead Sponsor: Istanbul Bilgi University

Brief 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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2020-01-01
• Study First Submitted: 2025-05-25
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Pain Score During Suctioning, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) pain subscore	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.

Secondary Outcome Measures

Name	Time	Method
Change in Oxygen Saturation (SpO₂) During and After Suctioning	During suctioning and 10 minutes post-procedure. SpO₂ measured by pulse oximetry.	To assess the impact of suction technique on oxygenation stability.
Change in Heart Rate (HR) During and After Suctioning	During suctioning and 10 minutes post-procedure. Heart Rate measured using bedside monitor.	To compare the effect of suction methods on cardiovascular stability.
Change in Sedation Score During Suctioning,N-PASS sedation subscore,	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

Trial Locations

Locations (1)

İstanbul Bilgi University; 🇹🇷 Şişli, Istanbul, Turkey