Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bronchopulmonary Dysplasia
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Serious adverse events
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Erik Allen Jensen
Assistant Professor of Pediatrics
Children's Hospital of Philadelphia
Eligibility Criteria
Inclusion 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 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
- •(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
- •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
Outcomes
Primary Outcomes
Serious adverse events
Time Frame: Until hospital discharge
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.
Proportion (%) of time per day with oxygen saturation <80%
Time Frame: During the 2 week trial
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.
Secondary Outcomes
- Proportion of GER episodes reaching the proximal pH-MII sensor(24 hours)
- Salivary and tracheal pepsin concentration(1 day prior to initiating the trial and on trial day 7 and 14.)
- Respiratory severity score(During the 2 week trial)
- Total number of pH (acid) only reflux episodes(24 hours)
- Intermittent hypoxemic episodes(During the 2 week trial)
- Total number of gastroesophageal reflux (GER) episodes(24 hours)
- Clinically diagnosed aspiration events(During the 2 week trial)
- Total daily narcotic exposure(During the 2 week trial)
- Salivary and tracheal total bile acid concentration(1 day prior to initiating the trial and on trial day 7 and 14.)
- Prolonged hypoxemic episodes(During the 2 week trial)
- Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale(During the 2 week trial)
- Feeding tube replacement(During the 2 week trial)