25 Participants Needed

Gastric vs Transpyloric Feeding for Bronchopulmonary Dysplasia

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Le Bonheur Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.16789

Who Is on the Research Team?

MW

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.
See 1 more

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
See 2 more

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?
2Treatment groups
Active Control
Group I: Gastric feedingActive Control1 Intervention
Group II: Transpyloric feedingActive Control1 Intervention

Find a Clinic Near You

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

Citations

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 ...
Individualizing Care in Severe Bronchopulmonary DysplasiaTranspyloric compared to gastric feedings modestly increased rates of hypoxemia among study participants.
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.
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) ...
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 ...
Early transpyloric vs gastric feeding in preterm infantsEarly 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.
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.govpubmed.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.
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 ...
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