Clinical trial NCT06002594: Examination of the Effectiveness of Nasal Irrigation Techniques in Infants With Nasal Congestion
Official title: The Effects of Two Different Nasal Irrigation Techniques on Physiological Parameters, Crying Duration, and Feeding in Relieving Nasal Congestion in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infection
Nasal Congestion and Inflammations
Keywords: infants
nasal irrigation
nasal lavage
feeding
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups were randomly selected and received two different treatments
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Effect of Low-Volume and High-Volume Nasal Irrigation Techniques on Infant's Physiological Parameters
timeFrame: 3 months
Secondary outcomes:
measure: The Effect of Nasal Irrigation Procedure on Procedure Duration, Infant Crying Duration, and Procedure Repetition Frequency
timeFrame: 3 months
Other outcomes:
measure: The Impact of Nasal Irrigation Techniques on Infant Feeding
timeFrame: 3 months
Locations:
city: İstanbul
country: Turkey
facility: University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital
state: Sarıyer
Study officials:
affiliation: University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital
name: Nevin AVŞAR GÖK
role: PRINCIPAL_INVESTIGATOR
References: