Clinical Trials Directory

Trials / Completed

CompletedNCT07111611

Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants

Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants During Non-Invasive Ventilation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Istanbul Bilgi University · Academic / Other
Sex
All
Age
32 Weeks – 37 Weeks
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURENon-Traumatic Nasopharyngeal Suction ProcedureA 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.

Timeline

Start date
2018-01-01
Primary completion
2019-01-01
Completion
2020-01-01
First posted
2025-08-08
Last updated
2025-08-08

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07111611. Inclusion in this directory is not an endorsement.