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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD113897-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Lucile Packard Children's Hospital | OTHER |
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The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature who have been diagnosed with bronchopulmonary dysplasia. The main questions this trial aims to answer are:
Does transpyloric as compared to gastric tube feeding result in differences in the amount of experienced hypoxemia (low oxygen level in the blood) or serious adverse events?
Does transpyloric as compared to gastric tube feeding reduce the frequency and severity of gastroesophageal reflux (GER) measured using 24 hour esophageal pH-multichannel intraluminal impedance (pH-MII) monitoring?
Participants will:
Undergo pre-trial 24 hour pH-MII monitoring to determine baseline severity of GER.
Be randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks.
Undergo repeat pH-MII at the end of the 2 week trial to assess for change in GER.
Undergo continuous pulse oximetry to record level of hypoxemia during the 2 week trial.
Undergo saliva and airway (if supported by a breathing tube) fluid collection to measure biomarkers of GER.
Be monitored clinically for possible adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transpyloric tube feeding | Experimental | Nasal or oral placed feeding tube with the distal end located within the second or third portion of the duodenum. Correct placement confirmed by radiograph. |
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| Gastric tube feeding | Experimental | Nasal or oral placed feeding tube with distal end located within the stomach. Correct placement confirmed by point of care aspirate pH testing or radiograph based on local clinical standard. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transpyloric tube feeding | Other | Tube feeding into the small bowel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (%) of time per day with oxygen saturation <80% | Oxygen saturation will be measured by continuous pulse oximetry throughout the 2 week trial. The proportion of time per day with an oxygen saturation (SpO2) less than 80% will be calculated and reported as a median value observed over the 2 week trial. | During the 2 week trial |
| Serious adverse events | A serious adverse event (SAE) will be defined as any adverse experience that is at least possibly related to the study intervention and results in any of the following outcomes:
| Until hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of gastroesophageal reflux (GER) episodes | The total number of GER episodes during a 24 hour period will be measured using 24 hour esophageal pH-multichannel intraluminal impedance (pH-MII) monitoring. Testing is performed by inserting a pH-MII catheter into the esophagus via the nasal or oral route. Reflux episodes are recorded during a 24 hour monitoring period and the total number is tabulated. 24 hour pH-MII testing will be performed prior to randomization and on day 14 (last day) of the clinical trial. |
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Inclusion Criteria:
(4) Full gastric tube feedings (≥100mL/kg/d) at the time of enrollment (5) Parental consent to participate
Note: At least 20 infants receiving invasive ventilation will be enrolled to enable endotracheal biomarker testing.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erik A Jensen, MD, MSCE | Contact | 267-648-2720 | jensene@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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Randomization procedures will be masked to initial pH-MII testing results.
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| Gastric tube feeding |
| Other |
Tube feeding into the stomach |
|
| 24 hours |
| Proportion of GER episodes reaching the proximal pH-MII sensor | The number of GER episodes detected by 24 hour esophageal pH-MII monitoring that reach the proximal sensor will be recorded and divided by the total number of recorded impedance episodes (regardless of esophageal height) | 24 hours |
| Total number of pH (acid) only reflux episodes | The total number of reflux episodes with a pH<4 will be recorded during 24 hour pH-MII monitoring | 24 hours |
| Salivary and tracheal pepsin concentration | Saliva and tracheal samples will be collected by gentle suctioning and analyzed for concentration of pepsin, a biomarker of GER. Quantification will be performed using commercially available assay. | 1 day prior to initiating the trial and on trial day 7 and 14. |
| Salivary and tracheal total bile acid concentration | Saliva and tracheal samples will be collected by gentle suctioning and analyzed for concentration of bile acids, a biomarker of gastro-duodeno reflux. Quantification will be performed using commercially available assay. | 1 day prior to initiating the trial and on trial day 7 and 14. |
| Intermittent hypoxemic episodes | Occurrence of hypoxemic episodes will be recorded using continuous pulse oximetry. Intermittent episodes will be defined as oxygen saturation (SpO2) values <80% lasting longer than 10 seconds. | During the 2 week trial |
| Prolonged hypoxemic episodes | Occurrence of hypoxemic episodes will be recorded using continuous pulse oximetry. Prolonged episodes will be defined as oxygen saturation (SpO2) values <80% lasting longer than 60 seconds. | During the 2 week trial |
| Clinically diagnosed aspiration events | Aspiration events will be diagnosed as will define aspiration as a witnessed regurgitation (milk in the mouth, clothing respiratory equipment, etc.) event with subsequent clinical decompensation (increase in inspired oxygen by an absolute difference of 20% or more or an increase in delivered mean airway pressure by at least 5cm H2O for ≥ 24 hours beginning within 24 hours of the observed regurgitation event. | During the 2 week trial |
| Respiratory severity score | Respiratory severity score is calculated as the delivered mean airway pressure multiplied by supplemental oxygen level. Values will be computed as the daily time weighted average. | During the 2 week trial |
| Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale | The FLACC scale assesses pain by observing five categories of behaviors and assigning a score of 0-2 to each category, resulting in a total score of 0-10: Face: Facial expressions, such as a smile, grimace, or frown Legs: Leg movement, such as kicking, drawing legs up, or remaining relaxed Activity: Movement, such as lying quietly, squirming, or remaining tense Cry: Crying, moaning, whimpering, or complaining Consolability: Response to comfort, such as being reassured by touching or hugging, or being difficult to console FLACC scores will be assessed during routine nursing care (at least twice daily) and summarized as median daily values | During the 2 week trial |
| Total daily narcotic exposure | Total dose of narcotic medications received during the 2 week trial will be tabulated in morphine and midazolam equivalents and summarized as mg/kg exposure. | During the 2 week trial |
| Feeding tube replacement | Number of times the feeding tube is replaced due to dysfunction or inadvertent dislodgment. | During the 2 week trial |
| Children's Hospital Colorado | Recruiting | Denver | Colorado | 80218 | United States |
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| Children's Mercy Hospital | Not yet recruiting | Kansas City | Missouri | 64108 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |