Postpyloric vs Gastric Feedings for Bronchopulmonary Dysplasia

Overseen By Vanessa J Young, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Cyanotic heart disease, genetic abnormalities, others

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

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of this treatment for Bronchopulmonary Dysplasia?

Some infants cannot tolerate gastric feeds and need postpyloric feeds to grow, as shown in research on infants in neonatal intensive care. However, current evidence does not support routine use of postpyloric feeding in critically ill patients, indicating that its benefits may vary depending on the specific condition and patient needs. ^{1 2 3 4 5}

Is postpyloric or gastric feeding safe for humans?

Research shows that nasogastric (through the nose to the stomach) feeding is generally safe in critically ill patients, although some complications like aspiration pneumonia (when food or liquid enters the lungs) can occur. Transpyloric feeding (beyond the stomach) has more complications and no clear benefits in low birth weight infants, suggesting that nasogastric feeding might be a safer option in these cases. ^{3 4 5 6 7}

How does the treatment of postpyloric vs gastric feedings for bronchopulmonary dysplasia differ from other treatments?

This treatment is unique because it involves feeding directly into the small intestine (postpyloric) rather than the stomach (gastric), which can be beneficial for infants who cannot tolerate stomach feeds. It is an alternative to parenteral nutrition (feeding through a vein) and is used when gastric emptying is impaired or when there is a risk of aspiration (food entering the lungs). ^{1 2 3 5 6}

What is the purpose of this trial?

The purpose of this study is to determine if postpyloric feedings effectively improve objective measures of pulmonary health in preterm infants with chronic lung disease when compared with nasogastric (NG) feedings. This research will (1) determine the optimal nutritional management to prevent a common and costly complication of prematurity, and (2) use a novel crossover design that examines outcomes of clinical endpoints alongside biomarkers.

Research Team

Jonathan Levin, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

This trial is for preterm infants born before 32 weeks who are between 34-44 weeks post-menstrual age, need respiratory support due to lung disease from prematurity, and can handle over 80 ml/kg/day of feedings through a tube. Infants with significant other illnesses or malformations affecting the lungs or digestion, recent serious gut issues, or temporary breathing support for reasons other than lung disease aren't eligible.

Inclusion Criteria

I have been on a ventilator or CPAP for at least 48 hours.

I need help breathing due to lung problems from being born early.

My baby was born before 32 weeks and is now 34-44 weeks old in terms of development since conception.

Exclusion Criteria

My infant has a condition affecting feeding through the mouth or stomach.

My infant has other serious health issues affecting their lungs.

My infant is on temporary breathing support not due to premature lung disease but for another reason like surgery recovery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Block 1

Participants receive either nasogastric (NG) or nasojejunal (NJ) feeds for a ten-day block

10 days

Daily monitoring

Treatment Block 2

Participants crossover to the alternate feeding method (NG or NJ) for another ten-day block

10 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Gastric Feeds
• Jejunal Feeds

Trial Overview The study compares two ways of feeding preterm infants with chronic lung disease: traditional nasogastric (NG) feeds versus jejunal (NJ) feeds placed past the stomach. It aims to see if NJ feedings improve lung health better than NG feedings using a crossover design where each infant receives both treatments in sequence.

Participant Groups

Group I: Group B: Jejunal Followed by Gastric Feeds Experimental Treatment 2 Interventions

Participants randomized into this group will begin with one ten-day block of nasojejunal (NJ, postpyloric) feeds followed by one ten-day block of nasogastric (NG) feeds.

Group II: Group A: Gastric Followed by Jejunal Feeds Experimental Treatment 2 Interventions

Participants randomized into this group will begin with one ten-day block of nasogastric (NG) feeds followed by one ten-day block of nasojejunal (NJ, postpyloric) feeds.

Gastric Feeds is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gastric Feeds for:

• Nutritional support in preterm infants
• Chronic lung disease management

Approved in European Union as Gastric Feeds for:

• Nutritional support in preterm infants
• Chronic lung disease management

Approved in Canada as Gastric Feeds for:

• Nutritional support in preterm infants
• Chronic lung disease management

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Findings from Research

In a study of 101 ICU patients over 21 days, nasogastric (NG) feeding did not show significant differences in outcomes compared to nasoduodenal (ND) feeding for less severely ill patients, indicating both routes are equally effective in this group.

However, for more severely ill patients, ND feeding resulted in better energy and protein intake, fewer complications, and shorter ICU stays compared to NG feeding, suggesting that the postpyloric route is more beneficial for those with greater illness severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severity of illness influences the efficacy of enteral feeding route on clinical outcomes in patients with critical illness. Huang, HH., Chang, SJ., Hsu, CW., et al.[2021]

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 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]

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]

Postpyloric feeding is a promising alternative to parenteral nutrition, especially for patients with conditions like gastroparesis and acute pancreatitis, where traditional feeding methods may not be effective.

This review highlights the advantages of postpyloric feeding, such as improved nutrient absorption, while also discussing the techniques for placing postpyloric feeding devices and the specific clinical situations where this method is indicated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-pyloric feeding. Niv, E., Fireman, Z., Vaisman, N.[2021]

In a study of 131 patients referred for nasojejunal feeding tube placement, only 59% met the established criteria for the procedure, indicating a significant gap in guideline adherence.

Among intensive care patients, only 50% met the criteria, and 35% had no increased gastric residues, suggesting that many patients may be receiving unnecessary tube placements, which could strain hospital resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical appraisal of indications for endoscopic placement of nasojejunal feeding tubes. Bouman, G., van Achterberg, T., Wanten, G.[2008]

In a study of 68 critically ill ventilated patients, conventional methods for placing nasoduodenal feeding tubes were largely unsuccessful, with only 10 patients achieving successful transpyloric placement.

In a follow-up assessment of 42 patients receiving nasogastric feeding, it was found to be safe, with 25 patients reaching their feeding goals within 72 hours, although 11 complications occurred, including one case of aspiration pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The failure of conventional methods to promote spontaneous transpyloric feeding tube passage and the safety of intragastric feeding in the critically ill ventilated patient. Marian, M., Rappaport, W., Cunningham, D., et al.[2009]

References

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

Severity of illness influences the efficacy of enteral feeding route on clinical outcomes in patients with critical illness. [2021]

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

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

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

Gastric versus postpyloric feeding. [2007]

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

Post-pyloric feeding. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A critical appraisal of indications for endoscopic placement of nasojejunal feeding tubes. [2008]

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

The failure of conventional methods to promote spontaneous transpyloric feeding tube passage and the safety of intragastric feeding in the critically ill ventilated patient. [2009]