Clinical trial NCT06534359: Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Official title: Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Gastroesophageal Reflux
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion (%) of time per day with oxygen saturation <80%
timeFrame: During the 2 week trial
measure: Serious adverse events
timeFrame: Until hospital discharge
Secondary outcomes:
measure: Total number of gastroesophageal reflux (GER) episodes
timeFrame: 24 hours
measure: Proportion of GER episodes reaching the proximal pH-MII sensor
timeFrame: 24 hours
measure: Total number of pH (acid) only reflux episodes
timeFrame: 24 hours
measure: Salivary and tracheal pepsin concentration
timeFrame: 1 day prior to initiating the trial and on trial day 7 and 14.
measure: Salivary and tracheal total bile acid concentration
timeFrame: 1 day prior to initiating the trial and on trial day 7 and 14.
measure: Intermittent hypoxemic episodes
timeFrame: During the 2 week trial
measure: Prolonged hypoxemic episodes
timeFrame: During the 2 week trial
measure: Clinically diagnosed aspiration events
timeFrame: During the 2 week trial
measure: Respiratory severity score
timeFrame: During the 2 week trial
measure: Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale
timeFrame: During the 2 week trial
measure: Total daily narcotic exposure
timeFrame: During the 2 week trial
measure: Feeding tube replacement
timeFrame: During the 2 week trial
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References: