Transpyloric vs Gastric Feeding for Bronchopulmonary Dysplasia

Recruiting at 2 trial locations

Overseen By Erik A Jensen, MD, MSCE

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Acid suppressants, GI promotility, Caffeine

Disqualifiers: Transpyloric feeding, Gastrostomy, Genetic abnormality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two feeding methods for premature infants with bronchopulmonary dysplasia, a lung condition requiring breathing support. Researchers aim to determine if feeding directly into the small intestine (transpyloric tube feeding) versus the stomach (gastric tube feeding) reduces acid reflux and low oxygen levels in the blood. Infants born before 32 weeks, who have ongoing breathing support and receive full tube feedings, are suitable candidates. Participants will be randomly assigned to one of the feeding methods and monitored for changes in reflux and oxygen levels. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve feeding methods for vulnerable infants.

Will I have to stop taking my current medications?

The trial requires that participants stop using gastric acid suppression, GI promotility drugs, or caffeine at least 7 days before enrolling.

What prior data suggests that transpyloric and gastric tube feeding are safe for infants with bronchopulmonary dysplasia?

Research has shown that feeding through a tube into the stomach is generally well-tolerated by infants with bronchopulmonary dysplasia. Most results are similar to other feeding methods, although one study found that some infants needed more oxygen during this type of feeding. This finding suggests that stomach tube feeding does not cause major problems for most infants.

For feeding through a tube that goes past the stomach (transpyloric feeding), results are mixed. Some studies indicate that this method might lead to lower oxygen levels compared to stomach feeding. However, other research suggests that transpyloric feeding can reduce issues like intestinal problems and breathing difficulties, including bronchopulmonary dysplasia.

In summary, both feeding methods have their advantages and disadvantages. Stomach feeding appears generally safe with few side effects. Transpyloric feeding might cause some low oxygen events but could also lower the risk of certain other complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different feeding techniques—gastric and transpyloric tube feeding—for managing bronchopulmonary dysplasia in infants. Unlike traditional gastric tube feeding, which places the feeding tube into the stomach, transpyloric feeding positions the tube further down in the duodenum. This could help reduce the risk of reflux and aspiration, which are common concerns in infants with this condition. By comparing these methods, researchers hope to find out which technique might better support lung health and nutrition in these vulnerable patients.

What evidence suggests that this trial's feeding methods could be effective for reducing gastroesophageal reflux in infants with bronchopulmonary dysplasia?

This trial will compare transpyloric tube feeding with gastric tube feeding for very low birth weight babies. Research has shown that feeding through a transpyloric tube, which delivers food directly to the small intestine, may lower the risk of death or lung problems like bronchopulmonary dysplasia (BPD). Studies have found that these babies often require fewer days on a breathing machine. Transpyloric feeding is also associated with fewer breathing issues, such as pauses in breathing (apnea) and slow heart rates (bradycardia). In contrast, feeding through a gastric tube, which sends food to the stomach, is common but does not show the same benefits in reducing problems like acid reflux. Overall, transpyloric feeding appears to lead to better outcomes for preterm infants with BPD. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Parental consent to participate

I am using a device to help with my breathing at the time of joining.

Birth <32 weeks' gestation

Exclusion Criteria

Active treatment with an investigational therapy as part of another interventional trial

I have received nutrition through a tube past my stomach within the last week.

I have a severe birth defect affecting my heart, lungs, or digestion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo pre-trial 24 hour pH-MII monitoring to determine baseline severity of GER

1 day

1 visit (in-person)

Treatment

Participants are randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks, with continuous monitoring and biomarker collection

2 weeks

Continuous monitoring

Follow-up

Participants undergo repeat pH-MII monitoring and are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gastric tube feeding
• Transpyloric tube feeding

Trial Overview 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.

How Is the Trial Designed?

Group I: Transpyloric tube feeding Experimental Treatment 1 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 feeding Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Transpyloric feeding in mechanically ventilated patients significantly reduces the incidence of ventilator-associated pneumonia (VAP) compared to gastric feeding, based on a systematic review of 8 randomized controlled trials involving 835 patients.

However, there were no significant differences in mortality, length of mechanical ventilation, ICU stay, or gastrointestinal complications like diarrhea and vomiting, indicating that while transpyloric feeding may help with VAP, its overall impact on patient outcomes needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-Benefit Profile of Gastric vs Transpyloric Feeding in Mechanically Ventilated Patients: A Meta-Analysis. Li, Z., Qi, J., Zhao, X., et al.[2016]

In a study involving 43 infants weighing under 1400 g, transpyloric feeding was associated with more complications and did not show any benefits in growth rate or nutritional indices compared to other feeding methods.

Bolus and continuous nasogastric feeding methods are recommended as better routine practices for low birth weight infants, as they resulted in fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial of continuous nasogastric, bolus nasogastric, and transpyloric feeding in infants of birth weight under 1400 g. Macdonald, PD., Skeoch, CH., Carse, H., et al.[2019]

Transpyloric feeding (TPF) significantly reduces the incidence of ventilator-associated pneumonia in severe traumatic brain injury (TBI) patients compared to gastric feeding (GF), with an odds ratio of 0.3, indicating a strong protective effect.

Patients receiving TPF also had better nutritional intake and fewer gastrointestinal complications, suggesting that TPF is not only safer but also more effective in delivering enteral nutrition in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric versus transpyloric feeding in severe traumatic brain injury: a prospective, randomized trial. Acosta-Escribano, J., Fernández-Vivas, M., Grau Carmona, T., et al.[2021]

Transpyloric feeding was evaluated in 46 very ill newborn infants on assisted ventilation and was found to be a simple and well-tolerated technique.

However, there was a notable risk of necrotising enterocolitis in 4 infants, highlighting a potential complication associated with this feeding method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpyloric feeding in 49 infants undergoing intensive care. Dryburgh, E.[2019]

Gastric bolus feeding is the preferred method for enteral feeding in most newborns due to its practicality and cost-effectiveness, while continuous gastric feeding may be better for unstable preterm infants or those with severe respiratory issues.

Early low-volume feedings are beneficial and safe, with daily increases of 10-20 ml/kg not linked to a higher risk of necrotizing enterocolitis, making them a safe approach for establishing enteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques of enteral feeding in the newborn. Macagno, F., Demarini, S.[2019]

In a quality improvement project involving 38 infants, the bedside placement of postpyloric tubes by nurses achieved a high success rate of 95.6%, indicating that this method is safe and effective for most preterm infants.

The study led to a policy change that reduced the need for x-rays during tube placement, minimizing radiation exposure for infants, particularly benefiting those who do not have congenital diaphragmatic hernia (CDH).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedside Placement of the Postpyloric Tube in Infants. Clifford, P., Ely, E., Heimall, L.[2017]

Transpyloric feeding in preterm infants was associated with a higher risk of gastrointestinal disturbances and increased mortality compared to gastric feeding, indicating potential safety concerns.

The systematic review of eight trials found no evidence that transpyloric feeding improved growth or development in preterm infants, suggesting it is not a beneficial feeding method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of transpyloric versus gastric tube feeding for preterm infants. McGuire, W., McEwan, P.[2019]

In a study of 20 preterm infants, those fed transpylorically with expressed human milk experienced higher fluid intakes and more rapid weight gain compared to a control group fed via nasogastric tube.

Transpyloric feeding is safer as it reduces the risk of aspiration after vomiting, making it a beneficial feeding method for small preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpyloric feeding in small preterm infants. Wolfsdorf, J., Makarawa, S., Fernandes, C., et al.[2019]

In a study of 54 critically ill patients over 14 months, there was no significant difference in aspiration rates between those fed through gastrically placed tubes (7% aspiration) and those fed through transpylorically placed tubes (13%).

Clinical assessments of aspiration were found to be unreliable, detecting only 60% of actual aspiration events, highlighting the need for more accurate monitoring methods in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equal aspiration rates in gastrically and transpylorically fed critically ill patients. Esparza, J., Boivin, MA., Hartshorne, MF., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7453998/

Individualizing Care in Severe Bronchopulmonary Dysplasia One infant received more supplemental oxygen during gastric feedings. The remaining study outcomes were similar between the feeding routes in ...

2. nature.com nature.com/articles/s41598-025-12066-8

Outcomes of extremely preterm infants with ... The need for home gastric tube feeding was significantly higher in severe BPD (OR 67.333, 95% CI 6.480–699.676, p < 0.001). Our findings ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06534359

Transpyloric Versus Gastric Feeding in Bronchopulmonary ... The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2781459

Rates of Bronchopulmonary Dysplasia Following ... A sustained low rate of BPD was observed in infants after the implementation of a detailed BPD system of care.

5. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.899785/full

Enteral Feeding/Total Fluid Intake Ratio Is Associated With ... A 10% increase in enteral feeding/total fluid intake ratio significantly reduced the risk of BPD by 55.6% [OR 0.444, 95% CI: 0.270–0.731]. These ...

6. nature.com nature.com/articles/s41372-019-0372-3

Early transpyloric vs gastric feeding in preterm infants Early TPF is associated with reduced risk of death or BPD among ELBW infants. Further investigation in the form of a randomized controlled trial is required.

7. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/s-0039-3401796

Feeding Outcomes for Infants with Bronchopulmonary ... Conclusion NG feeding for infants with BPD appears to be a viable treatment with fewer patients (29%) requiring GT placement. Gestational age and abnormal ...

8. publications.aap.org publications.aap.org/pediatrics/article/151/5/e2022060651/191114/Respiratory-Outcomes-for-Ventilator-Dependent

Respiratory Outcomes for Ventilator-Dependent Children ... To describe outpatient respiratory outcomes and center-level variability among children with severe bronchopulmonary dysplasia (BPD) who ...