Status
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal