Gastric vs Transpyloric Feeding for Bronchopulmonary Dysplasia

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Le Bonheur Children's Hospital

Disqualifiers: Gastrointestinal anomalies, Surgical feeding tube, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two feeding methods to determine which is best for infants with severe bronchopulmonary dysplasia (BPD), a lung condition, who also struggle with feeding. Infants will try both gastric feeding (feeding into the stomach) and transpyloric feeding (feeding past the stomach into the small intestine) for a few weeks each. The trial aims to assess how each method affects the infants' breathing. Babies born before 32 weeks and showing feeding issues like reflux or chronic aspiration may be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve feeding methods for vulnerable infants.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that feeding infants with bronchopulmonary dysplasia (BPD) through the stomach is a promising treatment option. Many infants tolerated it well, and fewer required more invasive feeding methods. However, more studies are needed to confirm its overall safety for infants with BPD.

Conversely, research has shown that feeding through a tube placed into the small intestine, known as transpyloric feeding, has been linked to negative outcomes in the hospital for infants with severe BPD. These findings raise concerns about its safety for these infants.

In summary, while stomach feeding appears to be better tolerated, feeding through the small intestine may pose risks for infants with severe BPD. Further research is necessary to fully understand the safety of both feeding methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional feeding methods for bronchopulmonary dysplasia, which typically involve gastric feeding, transpyloric feeding offers a unique approach by delivering nutrition directly to the small intestine. This method can potentially reduce the risk of aspiration and improve nutrient absorption, which is crucial for infants with this condition. Researchers are excited about comparing these two feeding methods because they aim to determine which method provides better respiratory outcomes and overall growth in these vulnerable patients.

What evidence suggests that this trial's feeding methods could be effective for bronchopulmonary dysplasia?

This trial will compare gastric feeding with transpyloric feeding for infants with severe bronchopulmonary dysplasia (BPD). Studies have shown that feeding infants directly into the stomach can sometimes cause lower oxygen levels in the blood, known as hypoxemia. Despite this, it is often used when infants require tube feeding into the stomach. Alternatively, transpyloric feeding, which involves feeding through a tube that bypasses the stomach and enters the small intestine, has been associated with fewer breathing issues and less frequent pauses in breathing and slow heart rate. Some research suggests that starting transpyloric feeding early may reduce the risk of death or BPD and decrease the need for breathing machines. Each feeding method has its advantages, and this trial aims to determine the best approach based on the infant's specific needs. ^{1 6 7 8 9}

Who Is on the Research Team?

Mark Weems, MD

Principal Investigator

University of Tennessee

Are You a Good Fit for This Trial?

This trial is for hospitalized infants with severe bronchopulmonary dysplasia (BPD) who are experiencing feeding intolerance. The study requires a crossover, meaning each infant will try both feeding methods for two weeks each.

Inclusion Criteria

I was born before reaching 32 weeks of pregnancy.

Currently admitted to the Le Bonheur NICU

I experience frequent heartburn, coughing after eating, or trouble with feeding.

Exclusion Criteria

Expected to remain hospitalized less than 8 weeks

I have a feeding tube or will get one in the next 8 weeks.

Known gastrointestinal anomalies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to 2 weeks of continuous gastric feeding or continuous transpyloric feeding, followed by a crossover to the other feeding mode for an additional 4 weeks.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gastric feeding
• Transpyloric feeding

Trial Overview

The study is testing continuous gastric feeding against continuous transpyloric feeding in these infants to see which method better supports their respiratory status and overall health during a four-week period.

How Is the Trial Designed?

Group I: Gastric feeding Active Control 1 Intervention

Subject will receive 2 weeks of continuous gastric feeding via a feeding tube in the stomach.

Group II: Transpyloric feeding Active Control 1 Intervention

Subject will receive 2 weeks of continuous transypyloric feeding via a feeding tube that passes through the stomach into the first portion of the small intestine.

Who Is Running the Clinical Trial?

Le Bonheur Children's Hospital

Lead Sponsor

Trials

29

Recruited

5,021,000+

Published Research Related to This Trial

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 involving 15 very preterm infants with severe bronchopulmonary dysplasia, transpyloric feedings were associated with a higher frequency of hypoxaemic events compared to gastric feedings, indicating a potential safety concern.

Transpyloric feedings resulted in a median of 7.5 hypoxaemic events per day, compared to 3 events per day with gastric feedings, suggesting that this feeding method may not be as safe for infants with respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding. Jensen, EA., Zhang, H., Feng, R., et al.[2021]

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]

In a study of 53 low birth-weight infants, intermittent gastric gavage feedings provided equivalent nutritional support compared to transpyloric feedings, with no significant differences in growth or health outcomes after 4 days.

Due to the higher risks, costs, and complexity associated with transpyloric feedings, they are not recommended as a standard feeding method for low birth-weight infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled study of transpyloric and intermittent gavage feeding in the small preterm infant. Pereira, GR., Lemons, JA.[2007]

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]

Current evidence does not support the routine use of postpyloric feeding over gastric feeding in critically ill patients, as randomized trials show only small differences in outcomes like pneumonia, but these studies are limited by their size and variability.

A standardized approach to enteral nutrition delivery is recommended to help clinicians determine which patients may truly benefit from small bowel feeding, optimizing the advantages while minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric versus postpyloric feeding. Drover, JW.[2007]

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 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]

Citations

1.

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 ...

2.

pmc.ncbi.nlm.nih.gov

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

Individualizing Care in Severe Bronchopulmonary Dysplasia

Transpyloric compared to gastric feedings modestly increased rates of hypoxemia among study participants.

3.

publications.aap.org

publications.aap.org/hospitalpediatrics/article/9/11/859/26720/Impact-of-SIMPLE-Feeding-Quality-Improvement

Impact of SIMPLE Feeding Quality Improvement Strategies ...

SIMPLE feeding strategy advances postnatal maturation and acquisition of feeding milestones irrespective of the severity of BPD and impacts the length of stay.

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frontiersin.org

frontiersin.org/journals/pediatrics/articles/10.3389/fped.2024.1496620/full

Use of transpyloric feeds in extremely low birth weight ...

Transpyloric feeding is associated with adverse in-hospital outcomes in infants with severe bronchopulmonary dysplasia. J Perinatol. (2024) ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05777512

Randomized Controlled Crossover Trial of Postpyloric ...

The purpose of this study is to determine if postpyloric feedings effectively improve objective measures of pulmonary health in preterm infants with chronic ...

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25380678/

Safety and Efficacy of Oral Feeding in Infants With BPD on ...

Controlled introduction of oral feedings in infants with BPD during NCPAP is safe and may accelerate the acquisition of oral feeding milestones.

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02142621

Transpyloric Feeding in Severe Bronchopulmonary ...

This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway complications of GER and and whether this methodology can aid in ...