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Compares treatment options for Bronchopulmonary Dysplasia
Official title Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
ClinicalTrials.gov ID: NCT06534359
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 12
You may be able to join if
- Birth \<32 weeks' gestation
- Current postmenstrual age of 36-65 weeks
- Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L/min flow...
- Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment (4)...
You likely can't join if
- Transpyloric feedings received within 7d of enrollment
- Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment
- History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding
- Plan to wean off positive airway pressure (for non-intubated people) or to be extubated to non-invasive support (for people receiving invasive...
- Known intolerance to transpyloric feeding
- Persistent \>20% endotracheal tube leak (for intubated people only)
See the full eligibility criteria
- Birth \<32 weeks' gestation
- Current postmenstrual age of 36-65 weeks
- Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L/min flow nasal cannular at 36 weeks' PMA) with subsequent need for prolonged...
- Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment (4) Full gastric tube feedings (≥100mL/kg/d) at the time of enrollment (5)...
- Transpyloric feedings received within 7d of enrollment
- Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment
- History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding
- Plan to wean off positive airway pressure (for non-intubated people) or to be extubated to non-invasive support (for people receiving invasive ventilation) within the 2wk trial
- Known intolerance to transpyloric feeding
- Persistent \>20% endotracheal tube leak (for intubated people only)
- Active treatment with an investigational therapy as part of another treatment trial
- severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Denver, Colorado, United States
- Kansas City, Missouri, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 12 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Denver, Colorado, United States; Kansas City, Missouri, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.