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Procedure

Gastric tube feeding for Bronchopulmonary Dysplasia

N/A
Waitlist Available
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Birth \<32 weeks' gestation
2. Current postmenstrual age of 36-65 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day prior to initiating the trial and on trial day 7 and 14.
Awards & highlights

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.

Who is the study for?
This trial is for premature infants with bronchopulmonary dysplasia and acid reflux. Infants must have a baseline level of gastroesophageal reflux measured before the trial. They cannot participate if they have conditions that would make the feeding methods unsafe or if their health status could interfere with the study's procedures.
What is being tested?
The study compares two ways of feeding infants: transpyloric tube feeding (directly into the small intestine) versus gastric tube feeding (into the stomach). It aims to see which method better reduces acid reflux and low oxygen levels in blood, using monitoring techniques over a 2-week period.
What are the potential side effects?
Potential side effects may include discomfort at the tube insertion site, risk of misplacement or dislodgement of tubes, possible irritation or infection, and adverse reactions related to changes in feeding location affecting digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and until hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion (%) of time per day with oxygen saturation <80%
Serious adverse events
Secondary study objectives
Clinically diagnosed aspiration events
Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale
Feeding tube replacement
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Transpyloric tube feedingExperimental Treatment1 Intervention
Nasal or oral placed feeding tube with the distal end located within the second or third portion of the duodenum. Correct placement confirmed by radiograph.
Group II: Gastric tube feedingExperimental Treatment1 Intervention
Nasal or oral placed feeding tube with distal end located within the stomach. Correct placement confirmed by point of care aspirate pH testing or radiograph based on local clinical standard.

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,001 Previous Clinical Trials
2,688,154 Total Patients Enrolled
12 Trials studying Bronchopulmonary Dysplasia
11,009 Patients Enrolled for Bronchopulmonary Dysplasia
Children's Hospital of PhiladelphiaLead Sponsor
718 Previous Clinical Trials
8,594,292 Total Patients Enrolled
8 Trials studying Bronchopulmonary Dysplasia
449 Patients Enrolled for Bronchopulmonary Dysplasia
~40 spots leftby Dec 2026