Feeding into the small intestine may reduce reflux and oxygen dips in fragile preterm infants
NCT ID NCT06534359
First seen Jun 30, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This pilot trial tests whether feeding directly into the small intestine (transpyloric) is better than feeding into the stomach (gastric) for very preterm infants with bronchopulmonary dysplasia, a chronic lung condition. The study will measure how often babies have low oxygen levels and serious side effects, and whether the feeding method reduces acid reflux. Sixty infants born before 32 weeks will be randomly assigned to one of the two feeding methods for two weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transpyloric tube feeding (feeding into the small intestine) and gastric tube feeding (feeding into the stomach)
- What this could lead to
- If transpyloric feeding works better, it could offer a safer way to feed very preterm infants with lung disease, reducing reflux and dangerous drops in oxygen levels.
- What could go wrong
- This is a small pilot study with only 60 infants, so results may not apply to all babies. The feeding tube into the small intestine may cause its own complications, and the trial is not designed to prove long-term benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 12 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Birth \<32 weeks' gestation 2. Current postmenstrual age of 36-65 weeks 3. 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 positive airway pressure and full enteral tube feedings 4. 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) Parental consent to participate Note: At least 20 infants receiving invasive ventilation will be enrolled to enable endotracheal biomarker testing. Exclusion Criteria: 1. Transpyloric feedings received within 7d of enrollment 2. Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment 3. History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding 4. Plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial 5. Known intolerance to transpyloric feeding 6. Persistent \>20% endotracheal tube leak (for intubated subjects only) 7. Active treatment with an investigational therapy as part of another interventional trial 8. severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital Colorado
RECRUITINGDenver, Colorado, 80218, United States
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Children's Mercy Hospital
NOT_YET_RECRUITINGKansas City, Missouri, 64108, United States
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Stanford University
RECRUITINGPalo Alto, California, 94304, United States
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- Could a lung ultrasound spot preemie lung disease before it starts?
- Could a Mother's Omega-3 supplement shield preterm Babies' lungs?