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Procedure

Transpyloric vs Gastric 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
Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment
Current postmenstrual age of 36-65 weeks
Must not have
Severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function
History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding
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

This trial aims to see if feeding premature infants with bronchopulmonary dysplasia directly into the small intestine (transpyloric tube feeding) is better than feeding into the stomach (ga

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
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I am using a device to help with my breathing at the time of joining.
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My baby is between 36 and 65 weeks old since birth.
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My baby has moderate to severe lung issues needing breathing support or mild issues but needed more care later.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a severe birth defect affecting my heart, lungs, or digestion.
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I have had surgery on my stomach or intestines that makes certain feedings not possible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day prior to initiating the trial and on trial day 7 and 14.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day prior to initiating the trial and on trial day 7 and 14. 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.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,774 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
721 Previous Clinical Trials
8,604,267 Total Patients Enrolled
~40 spots leftby Dec 2026
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