Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-24 @ 2:27 PM
NCT ID:
NCT06534359
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.
Study:
NCT06534359
Study Brief:
Protocol Section:
NCT06534359