Bronchopulmonary DysplasiaNCT06534359
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
A study testing Transpyloric tube feeding and Gastric tube feeding in people with Bronchopulmonary Dysplasia and Gastroesophageal Reflux, run by Children's Hospital of Philadelphia at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Bronchopulmonary Dysplasia, Gastroesophageal Reflux
- What is being tested?
- Transpyloric tube feeding and Gastric tube feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jul 2025to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 positive airway pressure and full enteral tube feedings
- Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment
- 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.
Who cannot join
- 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 subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial
- Known intolerance to transpyloric feeding
- Persistent >20% endotracheal tube leak (for intubated subjects only)
- Active treatment with an investigational therapy as part of another interventional trial
- severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Children's Hospital Colorado
Denver, Colorado, 80218
Kathleen Hannan, MD, MSCS, 414-803-1920, kathleen.hannan@childrenscolorado.org
- Not yet recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Krishna Dummula, MD, MPH, 305-528-0072
- Recruiting
Stanford University
Palo Alto, California, 94304
Erik Jensen, MD, MSCE, 267-648-2720, jensene@stanford.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Nicolas Bamat, MD, MSCE, 215-300-1356, bamatn@chop.edu
About this study
Official title: Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
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?
Read more
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.
- Being tested
- Transpyloric tube feeding, Gastric tube feeding
- Medical subject headings
- Bronchopulmonary Dysplasia, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpyloric tube feedingOther
Tube feeding into the small bowel
Gastric tube feedingOther
Tube feeding into the stomach
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transpyloric tube feeding |
| 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. Receives: Other: Gastric tube feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- death,
- a life-threatening event (at risk of death at the time of the event),
- prolongation of existing hospitalization beyond what would be expected for a preterm infant who requires extended respiratory support near and beyond term corrected gestation, or
- a persistent or significant disability/incapacity.
Measured: Until hospital discharge
Secondary outcomes (12)
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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: During the 2 week trial
Feeding tube replacement
Number of times the feeding tube is replaced due to dysfunction or inadvertent dislodgment.
Measured: During the 2 week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start15 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Lucile Packard Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534359
- Sponsor's protocol ID
- 24-022805
- Other IDs
- 1R21HD113897-01A1
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No