Examination of the Effectiveness of Nasal Irrigation Techniques in Infants With Nasal Congestion

Not Applicable

Completed

• Conditions: Upper Respiratory Tract Infection; Nasal Congestion and Inflammations
• Interventions: Other: group high-volume irrigation; Other: group low-volume irrigation

• Registration Number: NCT06002594
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

The research investigates the effects of high-volume and low-volume nasal irrigation techniques applied to relieve nasal congestion in infants with nasal congestion due to upper respiratory tract infections. The study examines the physiological parameters of infants who undergo nasal irrigation, crying duration, frequency of the procedure, and the baby's feeding patterns.

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 Timeline

• Study Start: 2019-08-15
• Primary Completion: 2019-10-29
• Study Completion: 2019-10-29
• Status Verified: 2023-08
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group high-volume irrigation	group high-volume irrigation	Nasal irrigation was performed using high-volume saline solution
group low-volume irrigation	group low-volume irrigation	Nasal irrigation was performed using low-volume saline solution

Primary Outcome Measures

Name	Time	Method
The Effect of Low-Volume and High-Volume Nasal Irrigation Techniques on Infant's Physiological Parameters	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.

Secondary Outcome Measures

Name	Time	Method
The Effect of Nasal Irrigation Procedure on Procedure Duration, Infant Crying Duration, and Procedure Repetition Frequency	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.

Trial Locations

Locations (1)

University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital; 🇹🇷 İstanbul, Sarıyer, Turkey