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

Trial Summary

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 data supports the effectiveness of transpyloric vs gastric feeding for bronchopulmonary dysplasia?

Research shows that some infants who cannot tolerate gastric feeds may benefit from postpyloric (beyond the stomach) feeding to meet their nutritional needs, although there is limited evidence specifically for infants. However, in preterm infants, transpyloric feeding did not show clear benefits over gastric feeding in terms of growth and development. ^{1 2 3 4 5}

Is transpyloric feeding safe for humans?

Transpyloric feeding has been associated with more complications compared to other feeding methods in infants, but it may reduce the risk of aspiration (food entering the lungs) in certain cases. It is generally considered safe when used appropriately, especially for those at risk of aspiration. ^{1 3 6 7 8}

How does transpyloric vs gastric feeding differ from other treatments for bronchopulmonary dysplasia?

Transpyloric feeding involves placing the feeding tube past the stomach into the small intestine, which may improve feeding tolerance and growth in preterm infants compared to gastric feeding, where the tube ends in the stomach. This method is unique because it bypasses the stomach, potentially reducing the risk of complications like reflux, which can be beneficial for infants with bronchopulmonary dysplasia. ^{1 2 6 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature who have been diagnosed with bronchopulmonary dysplasia. The main questions this trial aims to answer are: Does transpyloric as compared to gastric tube feeding result in differences in the amount of experienced hypoxemia (low oxygen level in the blood) or serious adverse events? Does transpyloric as compared to gastric tube feeding reduce the frequency and severity of gastroesophageal reflux (GER) measured using 24 hour esophageal pH-multichannel intraluminal impedance (pH-MII) monitoring? Participants will: Undergo pre-trial 24 hour pH-MII monitoring to determine baseline severity of GER. Be randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks. Undergo repeat pH-MII at the end of the 2 week trial to assess for change in GER. Undergo continuous pulse oximetry to record level of hypoxemia during the 2 week trial. Undergo saliva and airway (if supported by a breathing tube) fluid collection to measure biomarkers of GER. Be monitored clinically for possible adverse events.

Eligibility Criteria

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

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

3. 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]

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

Bedside Placement of the Postpyloric Tube in Infants. [2017]

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

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

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. Norway pubmed.ncbi.nlm.nih.gov

Techniques of enteral feeding in the newborn. [2019]

9. England pubmed.ncbi.nlm.nih.gov

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

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

The "Silk Road": A novel method for inserting transpyloric feeding tubes in low resource settings. [2020]