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Study design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence.
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This study will examine the efficacy of combined nebulized hypertonic saline with chest percussion therapy in patients age 0 to 24 months admitted to the general inpatient pediatrics unit with acute bronchiolitis. 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy will be administered every 6 hours of patients selected for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized Hypertonic Saline + Chest Percussion Therapy | Experimental | Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours. |
|
| Control Arm | No Intervention | Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized 3% sodium chloride solution | Drug | Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit. | Up to time of discharge (Approximately 1-5 days on average) |
| Time on Supplemental Oxygen Support | Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit. | Up to time of discharge (Approximately 1-5 days on average) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Respiratory Rate | Assessed every 4 hours and as needed in addition. | Up to time of discharge (Approximately 1-5 days on average) |
| Average Heart Rate | Assessed every 4 hours and as needed in addition. |
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Inclusion Criteria:
In order to be eligible to participate in this study (experimental arm), an individual must meet all of the following criteria:
Data collected for the control arm will be obtained via retrospective chart review for patients meeting the following inclusion criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
A potential study subject in the control arm via retrospective chart review who meets any of the following criteria will be excluded from this study:
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| Name | Affiliation | Role |
|---|---|---|
| Tuan Nguyen | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Mineola | New York | 11501 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Tuan Nguyen tuan.nguyen@nyulangone.org 405-535-7093 The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to tuan.nguyen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebulized Hypertonic Saline + Chest Percussion Therapy | Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours. Nebulized 3% sodium chloride solution: Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours. Chest percussion cups: The chest percussion cup is a small, flexible cup made of vinyl that is used to provide gentle chest wall vibrations to assist with airway clearance and is utilized in patients of all ages with sputum production, such as those with acute bronchiolitis. Administered every 6 hours while on supplemental oxygen therapy. |
| FG001 | Control Arm | Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Five patients were enrolled, but the study proved infeasible on the inpatient pediatrics unit due to uncontrolled variables and non-adherence (e.g., differing attending practices, forgotten order unlinks). Seventy retrospective controls were identified, but chart review and analysis were not done. No prospective subjects completed the protocol, no data were collected, and the study is closed with no data to analyze or publish.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebulized Hypertonic Saline + Chest Percussion Therapy | Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours. Nebulized 3% sodium chloride solution: Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours. Chest percussion cups: The chest percussion cup is a small, flexible cup made of vinyl that is used to provide gentle chest wall vibrations to assist with airway clearance and is utilized in patients of all ages with sputum production, such as those with acute bronchiolitis. Administered every 6 hours while on supplemental oxygen therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Hospital Stay | Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit. | Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Up to time of discharge (Approximately 1-5 days on average) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nebulized Hypertonic Saline + Chest Percussion Therapy | Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours. Nebulized 3% sodium chloride solution: Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours. Chest percussion cups: The chest percussion cup is a small, flexible cup made of vinyl that is used to provide gentle chest wall vibrations to assist with airway clearance and is utilized in patients of all ages with sputum production, such as those with acute bronchiolitis. Administered every 6 hours while on supplemental oxygen therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tuan Nguyen | NYU Langone Health | 405-535-7093 | tuan.nguyen@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2024 | Jan 7, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Chest percussion cups | Device | The chest percussion cup is a small, flexible cup made of vinyl that is used to provide gentle chest wall vibrations to assist with airway clearance and is utilized in patients of all ages with sputum production, such as those with acute bronchiolitis. Administered every 6 hours while on supplemental oxygen therapy. |
|
|
| Up to time of discharge (Approximately 1-5 days on average) |
| Average Pulse Oximetry Reading | Assessed every 4 hours and as needed in addition. | Up to time of discharge (Approximately 1-5 days on average) |
| Number of Caregivers Who Rate Child's Response as "Improved" | Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened." | Time of discharge (Approximately 1-5 days on average) |
| Number of Physicians Who Rate Child's Response as "Improved" | Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened." | Time of discharge (Approximately 1-5 days on average) |
| Retrospective chart review not completed |
|
| BG001 | Control Arm | Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial. |
| BG002 | Total | Total of all reporting groups |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Control Arm | Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial. |
|
| Primary | Time on Supplemental Oxygen Support | Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit. | Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Up to time of discharge (Approximately 1-5 days on average) |
|
|
| Secondary | Average Respiratory Rate | Assessed every 4 hours and as needed in addition. | Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Up to time of discharge (Approximately 1-5 days on average) |
|
|
| Secondary | Average Heart Rate | Assessed every 4 hours and as needed in addition. | Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Up to time of discharge (Approximately 1-5 days on average) |
|
|
| Secondary | Average Pulse Oximetry Reading | Assessed every 4 hours and as needed in addition. | Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Up to time of discharge (Approximately 1-5 days on average) |
|
|
| Secondary | Number of Caregivers Who Rate Child's Response as "Improved" | Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened." | Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Time of discharge (Approximately 1-5 days on average) |
|
|
| Secondary | Number of Physicians Who Rate Child's Response as "Improved" | Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened." | Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Time of discharge (Approximately 1-5 days on average) |
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Control Arm | Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial. | 0 | 70 | 0 | 70 | 0 | 70 |
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| D017670 |
| Sodium Compounds |