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

Primary Purpose

Upper Respiratory Tract Infection, Nasal Congestion and Inflammations

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
group low-volume irrigation
group high-volume irrigation
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Upper Respiratory Tract Infection focused on measuring infants, nasal irrigation, nasal lavage, feeding

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group low-volume irrigation

group high-volume irrigation

Arm Description

Nasal irrigation was performed using low-volume saline solution

Nasal irrigation was performed using high-volume saline solution

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2023
Last Updated
August 15, 2023
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06002594
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
October 29, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection, Nasal Congestion and Inflammations
Keywords
infants, nasal irrigation, nasal lavage, feeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups were randomly selected and received two different treatments
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group low-volume irrigation
Arm Type
Experimental
Arm Description
Nasal irrigation was performed using low-volume saline solution
Arm Title
group high-volume irrigation
Arm Type
Experimental
Arm Description
Nasal irrigation was performed using high-volume saline solution
Intervention Type
Other
Intervention Name(s)
group low-volume irrigation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
group high-volume irrigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Effect of Low-Volume and High-Volume Nasal Irrigation Techniques on Infant's Physiological Parameters
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The Effect of Nasal Irrigation Procedure on Procedure Duration, Infant Crying Duration, and Procedure Repetition Frequency
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
The Impact of Nasal Irrigation Techniques on Infant Feeding
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevin AVŞAR GÖK
Organizational Affiliation
University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital
City
İstanbul
State/Province
Sarıyer
ZIP/Postal Code
34453
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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