- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06002594
Examination of the Effectiveness of Nasal Irrigation Techniques in Infants With Nasal Congestion
The Effects of Two Different Nasal Irrigation Techniques on Physiological Parameters, Crying Duration, and Feeding in Relieving Nasal Congestion in Infants
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aims to investigate the effects of two different nasal irrigation techniques applied to relieve nasal congestion on infants' physiological parameters, crying duration, feeding habits, and the frequency of the procedure repetitions.
A randomized controlled experimental study was conducted with 80 infants aged 1-12 months who presented at the pediatric emergency clinic with nasal congestion due to upper respiratory tract infection. In the study, the 1st group of infants received low-volume saline solution, while the 2nd group received high-volume saline solution for nasal irrigation. Physiological parameters were measured before the procedure, immediately after the procedure, and 5 minutes after the procedure. Procedure duration and baby's crying duration were recorded. Subsequently, breastfeeding was initiated for the infants, and their physiological parameters were measured again during breastfeeding. Parental satisfaction levels with the procedure were also assessed. Finally, the frequency of the procedure repetitions was recorded.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sarıyer
-
İstanbul, Sarıyer, Turkey, 34453
- University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Infants diagnosed with Upper Respiratory Tract Infection and recommended nasal cleaning with saline solution by a physician,
- Infants whose parents provided consent for their participation in the research,
- Term-born infants aged 1 month to 12 months,
- Breastfed infants,
- Infants without chronic illnesses,
- Conscious infants,
Exclusion Criteria:
- Infants with congenital anomalies affecting the respiratory system (such as choanal atresia, etc.),
- Infants with allergic rhinitis,
- Infants who used antibiotics or corticosteroids before hospital admission,
- Infants with growth retardation, were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group low-volume irrigation
Nasal irrigation was performed using low-volume saline solution
|
Before the procedure, infants' physiological parameters were measured using the Nellcor Bedside SpO2 Patient Monitoring System.
The procedure duration and crying duration were recorded using the stopwatch on a Samsung Galaxy A50 phone.
Nasal irrigation was performed using 4 ml of 0.9% sodium chloride(NaCl) solution.
Physiological parameters were measured immediately after the procedure and five minutes later.
Subsequently, breastfeeding was initiated for the baby.
Physiological parameters during breastfeeding were measured, and parental satisfaction levels were evaluated.
Then, the frequency of procedure repetitions was recorded.
|
Experimental: group high-volume irrigation
Nasal irrigation was performed using high-volume saline solution
|
Before the procedure, infants' physiological parameters were measured using the Nellcor Bedside SpO2 Patient Monitoring System.
The procedure duration and crying duration were recorded using the stopwatch on a Samsung Galaxy A50 phone.
Nasal irrigation was performed using 20 ml of 0.9% NaCl solution.
Physiological parameters were measured immediately after the procedure and five minutes later.
Subsequently, breastfeeding was initiated for the baby.
Physiological parameters during breastfeeding were measured, and parental satisfaction levels were evaluated.
Then, the frequency of procedure repetitions was recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of Low-Volume and High-Volume Nasal Irrigation Techniques on Infant's Physiological Parameters
Time Frame: 3 months
|
Prior to low and high-volume nasal irrigation procedures, infants' average peripheral oxygen saturation (SpO2), average heart rate per minute, and average respiratory rate per minute will be measured immediately before the procedure, immediately after the procedure, and five minutes after the procedure.
The aim is to examine the effect of irrigation on physiological parameters.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of Nasal Irrigation Procedure on Procedure Duration, Infant Crying Duration, and Procedure Repetition Frequency
Time Frame: 3 months
|
Since the irrigation procedure can be distressing for the infant, two stopwatches were initiated to measure the duration of crying associated with the procedure.
One was started just before the nasal irrigation procedure, and the other when the infant began crying.
The first stopwatch was stopped after the procedure, while the second stopwatch was stopped when the infant's crying ceased.
For infants with persistent post-irrigation nasal congestion, the procedure was repeated at 15-minute intervals, and the number of procedure repetitions was recorded.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Impact of Nasal Irrigation Techniques on Infant Feeding
Time Frame: 3 months
|
After the nasal irrigation procedures, breastfeeding was initiated.
During breastfeeding, average peripheral oxygen saturation (SpO2), average heart rate per minute, and average respiratory rate per minute were recorded.
Following breastfeeding, mothers were asked to assess their current breastfeeding performance compared to the baby's performance before the procedure, and their satisfaction level with the procedure was recorded by inquiring about their level of contentment.
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nevin AVŞAR GÖK, University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sislietfal-SBF-NAG-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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