Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Gastroesophageal Reflux; Bronchopulmonary Dysplasia

Treatments: Other: Transpyloric tube feeding; Other: Gastric tube feeding

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06534359

23-021698

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Transpyloric tube feeding

Experimental group

Description:

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.

Treatment:

Other: Transpyloric tube feeding

Gastric tube feeding

Experimental group

Description:

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.

Treatment:

Other: Gastric tube feeding