xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002594</url>
    </required_header>
    <id_info>
      <org_study_id>Sislietfal-SBF-NAG-01</org_study_id>
      <nct_id>NCT06002594</nct_id>
    </id_info>
    <brief_title>Examination of the Effectiveness of Nasal Irrigation Techniques in Infants With Nasal Congestion</brief_title>
    <official_title>The Effects of Two Different Nasal Irrigation Techniques on Physiological Parameters, Crying Duration, and Feeding in Relieving Nasal Congestion in Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sisli Hamidiye Etfal Training and Research Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The research investigates the effects of high-volume and low-volume nasal irrigation&#xD;
        techniques applied to relieve nasal congestion in infants with nasal congestion due to upper&#xD;
        respiratory tract infections. The study examines the physiological parameters of infants who&#xD;
        undergo nasal irrigation, crying duration, frequency of the procedure, and the baby's feeding&#xD;
        patterns.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to investigate the effects of two different nasal irrigation techniques&#xD;
        applied to relieve nasal congestion on infants' physiological parameters, crying duration,&#xD;
        feeding habits, and the frequency of the procedure repetitions.&#xD;
  &#xD;
        A randomized controlled experimental study was conducted with 80 infants aged 1-12 months who&#xD;
        presented at the pediatric emergency clinic with nasal congestion due to upper respiratory&#xD;
        tract infection. In the study, the 1st group of infants received low-volume saline solution,&#xD;
        while the 2nd group received high-volume saline solution for nasal irrigation. Physiological&#xD;
        parameters were measured before the procedure, immediately after the procedure, and 5 minutes&#xD;
        after the procedure. Procedure duration and baby's crying duration were recorded.&#xD;
        Subsequently, breastfeeding was initiated for the infants, and their physiological parameters&#xD;
        were measured again during breastfeeding. Parental satisfaction levels with the procedure&#xD;
        were also assessed. Finally, the frequency of the procedure repetitions was recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 15, 2019</start_date>
    <completion_date type="Actual">October 29, 2019</completion_date>
    <primary_completion_date type="Actual">October 29, 2019</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>two groups were randomly selected and received two different treatments</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Effect of Low-Volume and High-Volume Nasal Irrigation Techniques on Infant's Physiological Parameters</measure>
      <time_frame>3 months</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Effect of Nasal Irrigation Procedure on Procedure Duration, Infant Crying Duration, and Procedure Repetition Frequency</measure>
      <time_frame>3 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>The Impact of Nasal Irrigation Techniques on Infant Feeding</measure>
      <time_frame>3 months</time_frame>
      <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.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Upper Respiratory Tract Infection</condition>
    <condition>Nasal Congestion and Inflammations</condition>
    <arm_group>
      <arm_group_label>group low-volume irrigation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nasal irrigation was performed using low-volume saline solution</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group high-volume irrigation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nasal irrigation was performed using high-volume saline solution</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>group low-volume irrigation</intervention_name>
      <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.</description>
      <arm_group_label>group low-volume irrigation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>group high-volume irrigation</intervention_name>
      <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.</description>
      <arm_group_label>group high-volume irrigation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Infants diagnosed with Upper Respiratory Tract Infection and recommended nasal&#xD;
               cleaning with saline solution by a physician,&#xD;
  &#xD;
            -  Infants whose parents provided consent for their participation in the research,&#xD;
  &#xD;
            -  Term-born infants aged 1 month to 12 months,&#xD;
  &#xD;
            -  Breastfed infants,&#xD;
  &#xD;
            -  Infants without chronic illnesses,&#xD;
  &#xD;
            -  Conscious infants,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infants with congenital anomalies affecting the respiratory system (such as choanal&#xD;
               atresia, etc.),&#xD;
  &#xD;
            -  Infants with allergic rhinitis,&#xD;
  &#xD;
            -  Infants who used antibiotics or corticosteroids before hospital admission,&#xD;
  &#xD;
            -  Infants with growth retardation, were excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>12 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nevin AVŞAR GÖK</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital</name>
        <address>
          <city>İstanbul</city>
          <state>Sarıyer</state>
          <zip>34453</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Nevin Avsar</investigator_full_name>
      <investigator_title>nurse</investigator_title>
    </responsible_party>
    <keyword>infants</keyword>
    <keyword>nasal irrigation</keyword>
    <keyword>nasal lavage</keyword>
    <keyword>feeding</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Tract Infections</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002594
  org study id: Sislietfal-SBF-NAG-01
  nct id: NCT06002594
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: two groups were randomly selected and received two different treatments
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: The Effect of Low-Volume and High-Volume Nasal Irrigation Techniques on Infant's Physiological Parameters
  time frame: 3 months
  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.
  measure: The Effect of Nasal Irrigation Procedure on Procedure Duration, Infant Crying Duration, and Procedure Repetition Frequency
  time frame: 3 months
  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.
  measure: The Impact of Nasal Irrigation Techniques on Infant Feeding
  time frame: 3 months
  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.
  arm group label: group low-volume irrigation
  arm group type: Experimental
  description: Nasal irrigation was performed using low-volume saline solution
  arm group label: group high-volume irrigation
  arm group type: Experimental
  description: Nasal irrigation was performed using high-volume saline solution
  intervention type: Other
  intervention name: group low-volume irrigation
  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.
  arm group label: group low-volume irrigation
  intervention type: Other
  intervention name: group high-volume irrigation
  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.
  arm group label: group high-volume irrigation
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: 12 Months
  healthy volunteers: No
  last name: Nevin AVŞAR GÖK
  role: Principal Investigator
  affiliation: University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
  investigator full name: Nevin Avsar
  investigator title: nurse
  mesh term: Respiratory Tract Infections
  mesh term: Inflammation
  sharing ipd: No