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

NCT06002594 | Completed

• 1 other identifier: Sislietfal-SBF-NAG-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Tract Infection; Nasal Congestion and Inflammations

Keywords

infants; nasal irrigation; nasal lavage; feeding

Outcome Measures

Primary Outcomes (1)

• The Effect of Low-Volume and High-Volume Nasal Irrigation Techniques on Infant's Physiological Parameters

  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 Outcomes (1)

• The Effect of Nasal Irrigation Procedure on Procedure Duration, Infant Crying Duration, and Procedure Repetition Frequency

  3 months

Other Outcomes (1)

• The Impact of Nasal Irrigation Techniques on Infant Feeding

  3 months

Study Arms (2)

group low-volume irrigation

EXPERIMENTAL

Nasal irrigation was performed using low-volume saline solution

Other: group low-volume irrigation

group high-volume irrigation

EXPERIMENTAL

Nasal irrigation was performed using high-volume saline solution

Other: group high-volume irrigation

Interventions

group low-volume irrigation OTHER

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.

group low-volume irrigation

group high-volume irrigation OTHER

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.

group high-volume irrigation

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Sarıyer, 34453, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Nasal Obstruction; Inflammation

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nevin AVŞAR GÖK

  University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Model Details: two groups were randomly selected and received two different treatments

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 21, 2023
• Study Start: August 15, 2019
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)