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

Trial Summary

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.

What data supports the effectiveness of the treatment Gastric feeding, Transpyloric feeding for Bronchopulmonary Dysplasia?

Research shows that feeding into the small bowel (transpyloric feeding) is often recommended to improve nutrient delivery for critically ill patients, which might help reduce complications. However, studies have not consistently shown clear benefits of transpyloric feeding over gastric feeding in terms of growth or reducing complications in infants, and current evidence does not support routine use of transpyloric feeding in critically ill patients. ^{1 2 3 4 5}

Is transpyloric feeding safe for infants?

Transpyloric feeding in infants, especially those with low birth weight, has been associated with more complications compared to other feeding methods like nasogastric feeding. While it may offer some benefits like reduced risk of aspiration (breathing in food or liquid) and faster weight gain, it also involves greater risks and costs, making it less recommended as a routine feeding method. ^{2 3 6 7 8}

How does gastric vs transpyloric feeding treatment differ for bronchopulmonary dysplasia?

Gastric and transpyloric feeding differ in the route of administration; gastric feeding delivers nutrients directly to the stomach, while transpyloric feeding bypasses the stomach and delivers nutrients directly to the small intestine. This can be beneficial in reducing the risk of aspiration (inhaling food into the lungs) and may lead to more rapid weight gain in preterm infants, although it may also come with more complications. ^{1 2 6 7 9}

What is the purpose of this trial?

Hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. Subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. Respiratory status will be assessed to determine the optimal feeding mode for each infant.

Research Team

Mark Weems, MD

Principal Investigator

University of Tennessee

Eligibility Criteria

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

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

Expected to remain hospitalized less than 8 weeks

Known gastrointestinal anomalies

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gastric versus transpyloric feeding in severe traumatic brain injury: a prospective, randomized trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Randomised trial of continuous nasogastric, bolus nasogastric, and transpyloric feeding in infants of birth weight under 1400 g. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Systematic review of transpyloric versus gastric tube feeding for preterm infants. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Gastric versus postpyloric feeding. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Risk-Benefit Profile of Gastric vs Transpyloric Feeding in Mechanically Ventilated Patients: A Meta-Analysis. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Transpyloric feeding in small preterm infants. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Controlled study of transpyloric and intermittent gavage feeding in the small preterm infant. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Equal aspiration rates in gastrically and transpylorically fed critically ill patients. [2021]