Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-02 @ 1:02 AM
Study NCT ID:
NCT06534359
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
Official Title:
Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: