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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day prior to initiating the trial and on trial day 7 and 14.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met