Health TrialsbyHealthPanel

Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia

ConditionsBronchopulmonary DysplasiaGastroesophageal Reflux
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-12
SponsorChildren's Hospital of Philadelphia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transpyloric tube feeding

    Other intervention

    Tube feeding into the small bowel

  • Gastric tube feeding

    Other intervention

    Tube feeding into the stomach

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Transpyloric tube feedingExperimental treatment 1 intervention
Group B: Gastric tube feedingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During the 2 week trial
2

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.

Time frame
Until hospital discharge

Secondary outcomes

1

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.

Time frame
24 hours
2

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)

Time frame
24 hours
3

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

Time frame
24 hours
4

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.

Time frame
1 day prior to initiating the trial and on trial day 7 and 14.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Lucile Packard Children's Hospital

Collaborator

Source ClinicalTrials.gov
Apply now