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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to provide nutrition to preterm infants with chronic lung disease by comparing two feeding methods: gastric feeds (through the stomach) and jejunal feeds (bypassing the stomach). The aim is to determine which method better supports lung health and overall outcomes for these infants. Preterm babies requiring ongoing breathing support and capable of handling a certain amount of tube feeding might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance care for future preterm infants.

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 prior data suggests that these feeding methods are safe for preterm infants?

Research has shown that feeding through the stomach is generally well-tolerated in infants with bronchopulmonary dysplasia (BPD). One study found that only a few infants required extra oxygen during these feeds, with results similar to other feeding methods. Another study found that 29% of infants using a tube from the nose to the stomach (NG feeding) needed a more permanent feeding tube, indicating that most infants managed well without it.

However, the safety of feeding directly into the small intestine (jejunal feeding) in infants with BPD remains less certain. Some experts consider it safe and effective for certain children, but reports of complications during hospital stays, especially for infants with severe BPD, suggest otherwise. This indicates that feeding into the small intestine might not be as well-tolerated as feeding through the stomach.

In summary, current research suggests that feeding through the stomach is better tolerated, while feeding into the small intestine may require more caution due to potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different feeding methods to potentially improve outcomes for infants with bronchopulmonary dysplasia (BPD). Traditional care often involves gastric feeding, but this study is examining the effects of jejunal (postpyloric) feeding as well. Jejunal feeding may bypass the stomach, potentially reducing the risk of aspiration and improving nutrient absorption. By comparing these two methods, researchers hope to determine if one approach offers better support for infants with BPD, possibly leading to improved growth and reduced respiratory complications.

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

This trial will compare two feeding methods for babies with bronchopulmonary dysplasia (BPD). Participants in Group A will start with nasogastric (NG) feeds followed by nasojejunal (NJ, postpyloric) feeds, while those in Group B will begin with NJ feeds followed by NG feeds. Research has shown that feeding through an NG tube is beneficial for babies with BPD, as it reduces the need for a more permanent feeding tube. Studies have found that feeding directly into the small intestine (jejunum) can result in fewer breathing pauses and slow heart rates in premature babies. However, some evidence suggests that this type of feeding might be linked to worse hospital outcomes. Both feeding methods have their advantages and disadvantages, and the best choice may depend on each baby's unique situation and response. More research is needed to determine which feeding method might improve lung health in these infants. ^{1 3 5 6 7}

Who Is on the Research Team?

Jonathan Levin, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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 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]

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]

Citations

1. 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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31887745/

Feeding Outcomes for Infants with Bronchopulmonary ... NG feeding for infants with BPD appears to be a viable treatment with fewer patients (29%) requiring GT placement.

3. nature.com nature.com/articles/s41372-019-0372-3

Early transpyloric vs gastric feeding in preterm infants Twenty-seven percent received early TPF. Death or BPD occurred in 58% of infants who received early TPF compared with 67% of infants who ...

4. 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 ...

5. 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) ...

6. 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 ...

7. 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 ...