Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534359
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None