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Loss of equipoise among enrolling clinicians, as well as emergence of external literature showing safety of nasogastric tube (NGT) feeds.
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The purpose of the study is to compare two ways (nasogastric tube (NGT) and nasoduodenal tube (NDT)) to provide nutrition to infants admitted to the hospital for viral bronchiolitis and who require high flow nasal cannula therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nasogastric tube (NGT) feeding | Active Comparator |
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| nasoduodenal tube (NDT) feeding | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasogastric tube (NGT) feeding | Device | A nasogastric tube goes from the nose to the stomach. |
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| Measure | Description | Time Frame |
|---|---|---|
| Length of Respiratory Supprt | from the time of hospital admission to discharge (about 6 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Emesis | from the time of hospital admission to discharge (about 6 days) | |
| Peak Respiratory Support in Liters Per Minute | from the time of hospital admission to discharge (about 6 days) |
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Inclusion Criteria:
- All admitted patients for bronchiolitis requiring high flow nasal cannula therapy at Children's Memorial Hermann
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Parlar-Chun, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31061025 | Derived | Parlar-Chun R, Lafferty-Prather M, Gonzalez V, Pedroza C, Gourishankar A. Protocol: randomised trial to compare nasoduodenal tube and nasogastric tube feeding in infants with bronchiolitis on high-flow nasal cannula; Bronchiolitis and High-flow nasal cannula with Enteral Tube feeding Randomised (BHETR) trial. BMJ Open. 2019 May 5;9(5):e025405. doi: 10.1136/bmjopen-2018-025405. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasogastric Tube (NGT) Feeding | Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach. |
| FG001 | Nasoduodenal Tube (NDT) Feeding | Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Mar 26, 2018 |
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| Nasoduodenal tube (NDT) feeding | Device | A nasoduodenal tube goes from the nose to the duodenum. |
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| Number of Chest X-rays Obtained Among All Participants | from the time of hospital admission to discharge (about 6 days) |
| Number of Participants Who Revisited the Emergency Room (ER) | 7 days after discharge from hospital |
| Number of Participants Who Revisited the Emergency Room (ER) | 30 days after discharge from hospital |
| Number of Participants Who Were Readmitted to the Hospital | 7 days after discharge from initial hospital visit |
| Number of Participants Who Were Readmitted to the Hospital | 30 days after discharge from initial hospital visit |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasogastric Tube (NGT) Feeding | Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach. |
| BG001 | Nasoduodenal Tube (NDT) Feeding | Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Number of Participants with Term Gestation | Count of Participants | Participants |
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| Number of Participants with Preterm Gestation | Count of Participants | Participants |
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| Number of participants with spontaneous vaginal delivery (SVD) | Count of Participants | Participants |
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| Number of participants with cesarean delivery (CD) | Count of Participants | Participants |
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| Number of participants with low risk of aspiration | Count of Participants | Participants |
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| Number of participants with high risk of aspiration | Count of Participants | Participants |
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| 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 Respiratory Supprt | Posted | Mean | Standard Deviation | hours | from the time of hospital admission to discharge (about 6 days) |
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| Secondary | Number of Participants With Emesis | Posted | Count of Participants | Participants | from the time of hospital admission to discharge (about 6 days) |
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| Secondary | Peak Respiratory Support in Liters Per Minute | Posted | Mean | Standard Deviation | liters per minute | from the time of hospital admission to discharge (about 6 days) |
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| Secondary | Number of Chest X-rays Obtained Among All Participants | Posted | Number | chest x-rays | from the time of hospital admission to discharge (about 6 days) |
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| Secondary | Number of Participants Who Revisited the Emergency Room (ER) | 2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these participants. | Posted | Count of Participants | Participants | 7 days after discharge from hospital |
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| Secondary | Number of Participants Who Revisited the Emergency Room (ER) | 2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these participants. | Posted | Count of Participants | Participants | 30 days after discharge from hospital |
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| Secondary | Number of Participants Who Were Readmitted to the Hospital | 2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these 5 participants. | Posted | Count of Participants | Participants | 7 days after discharge from initial hospital visit |
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| Secondary | Number of Participants Who Were Readmitted to the Hospital | 2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these 5 participants. | Posted | Count of Participants | Participants | 30 days after discharge from initial hospital visit |
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From the time of enrollment to discharge (about 6 days)
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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 | Nasogastric Tube (NGT) Feeding | Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach. | 0 | 20 | 0 | 20 | 1 | 20 |
| EG001 | Nasoduodenal Tube (NDT) Feeding | Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum. | 0 | 20 | 1 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nose bleed | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Parlar-Chun, MD | The University of Texas Health Science Center at Houston | 713-500-5666 | Raymond.L.Chun@uth.tmc.edu |
| Mar 6, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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