Nasogastric Tubes for Bronchiolitis

Overseen By Leroy Crawley, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Arkansas Children's Hospital Research Institute

Disqualifiers: Bacterial pneumonia, Cranio-facial anomalies, Congenital heart disease, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 60 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether nasogastric tubes (small tubes placed through the nose into the stomach) improve breathing in young children with bronchiolitis. Bronchiolitis, a common lung infection, can make breathing difficult for infants. The trial focuses on children already receiving oxygen through a high-flow nasal cannula, a special tube that delivers oxygen into the nose. Eligible participants are children under 2 years old with a bronchiolitis diagnosis who are using high-flow oxygen support. Children with conditions like bacterial pneumonia or certain medical histories are not eligible. As an unphased trial, this study provides a unique opportunity to enhance understanding of new methods to assist children with breathing difficulties.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that nasogastric tube placement is safe for patients with bronchiolitis?

Research has shown that nasogastric tubes are generally safe for infants with bronchiolitis who require extra oxygen. Studies have found that these tubes are well-tolerated by these infants. Specifically, infants with bronchiolitis using high-flow nasal cannula (a type of oxygen support) tolerate nasogastric tubes well.

One study compared nasoduodenal and nasogastric tubes and found both to be safe, with no major differences in safety. Additionally, tube feeding is considered a safe alternative to IV fluids for these infants.

Overall, evidence suggests that nasogastric tubes do not cause significant side effects in this group, supporting their use as a safe option for managing bronchiolitis with high-flow oxygen therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using nasogastric tubes for bronchiolitis because it offers a different approach to managing the condition compared to standard treatments, like bronchodilators and steroids, which primarily target the airways. Unlike medications, nasogastric tubes provide direct nutritional support and hydration, which can be crucial for infants struggling to feed due to breathing difficulties. This method could potentially improve recovery times and overall outcomes by ensuring that young patients receive the necessary nutrients and fluids without the added complexity of drug side effects.

What evidence suggests that nasogastric tube placement is effective for bronchiolitis?

Research has shown that placing a nasogastric (NG) tube is generally well-tolerated in infants with bronchiolitis, especially when receiving oxygen through a high-flow nasal cannula (HFNC). This trial will evaluate the use of NG tubes for feeding in this context. Studies suggest that using NG tubes for feeding does not worsen breathing problems. Although direct evidence does not show that NG tubes improve breathing, they are often used to help feed infants who have trouble eating by mouth. This ensures they receive necessary nutrition while sick. Overall, using an NG tube is considered a safe and practical way to manage bronchiolitis in infants. ^{1 3 4 6 7}

Who Is on the Research Team?

David Spiro, MD, MPH

Principal Investigator

AR Children's Hospital

Are You a Good Fit for This Trial?

This trial is for babies and toddlers up to 23 months old with bronchiolitis who are receiving oxygen through a high-flow nasal cannula. It's not suitable for those with tracheostomy, short gut syndrome, congenital heart disease, G-tube dependence, cranio-facial anomalies or bacterial pneumonia.

Inclusion Criteria

My doctor diagnosed me with bronchiolitis.

I am under 2 years old.

You are using a high-flow nasal cannula at a rate of 4 liters per minute or more.

Exclusion Criteria

You have had a condition called short gut syndrome in the past.

I was born with a heart condition.

I have had or currently have a tracheostomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive nasogastric tube placement for gastric decompression while on high-flow nasal cannula

60 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 days

What Are the Treatments Tested in This Trial?

Interventions

• Nasogastric tube placement

Trial Overview The study is testing if using nasogastric tubes to remove stomach contents can help ease breathing difficulties in young patients with bronchiolitis on high-flow oxygen therapy.

How Is the Trial Designed?

Group I: Nasogastric tube placement Experimental Treatment 1 Intervention

Nasogastric tube placement is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration
• Removal of gastric contents

Approved in United States as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration
• Removal of gastric contents
• Bowel obstruction
• Ileus

Approved in Canada as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration
• Removal of gastric contents

Approved in Japan as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration

Approved in China as NG tube for:

• Gastric decompression
• Nutritional support

Approved in Switzerland as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration

Who Is Running the Clinical Trial?

Arkansas Children's Hospital Research Institute

Lead Sponsor

Trials

141

Recruited

5,025,000+

Published Research Related to This Trial

Nasogastric tubes are useful for short-term feeding when oral intake isn't possible, but their insertion carries risks, including potential misplacement into the lungs.

A case is highlighted where a nasogastric tube was incorrectly positioned in both main bronchi, emphasizing the need for a chest x-ray after placement to prevent serious respiratory complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadvertent insertion of a nasogastric tube into both main bronchi of an awake patient: a case report. Takwoingi, YM.[2021]

A survey of 205 nurses from 166 institutions revealed that while 64% believe radiographs and 24% believe pH measurements are best practices for confirming nasogastric tube (NGT) placement, actual usage shows that only 42% use pH measurement and 23% use radiographs, indicating a gap between belief and practice.

Despite an overall increase in the adoption of evidence-based practices (EBP) for NGT placement verification since the NOVEL project, significant variability remains within institutions, particularly in Neonatal Intensive Care Units (NICUs), where non-evidence-based methods are still commonly used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of methods used to verify nasogastric feeding tube placement in hospitalized infants and children - A follow-up study. Northington, L., Kemper, C., Rempel, G., et al.[2022]

In a study of 290 children with respiratory infections, the presence of indwelling nasogastric tubes (NGTs) did not significantly affect the rate of pulmonary aspiration, with rates of 29.8% in NGT patients compared to 32.3% in those without NGTs.

The results suggest that while pulmonary aspiration rates were high in children with underlying health issues, NGT feeding did not compromise the accuracy of salivagram tests used to assess aspiration risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nasogastric tube on salivagram result in paediatric patients. Wu, H., Zhao, X., Ting Kung, B., et al.[2020]

Caregivers often lack knowledge about how to properly place nasogastric (NG) tubes in children for enteral nutrition, highlighting a need for better education and resources.

The article offers best practices and templates for caregiver education, drawing on effective patient education materials from Canadian and Australian programs to improve the training of caregivers in NG tube placement and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Nasogastric Feeding Tubes for Children at Home: A Template for Caregiver Education. Lyman, B., Rempel, G., Windsor, K., et al.[2018]

Nearly 800,000 nasogastric tubes are utilized annually in the NHS, highlighting their importance in medical care.

These tubes are especially common in children's nursing, particularly in neonatal units and children's wards during the winter bronchiolitis season, indicating their critical role in managing respiratory conditions in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning through leadership. Marlow, T.[2019]

In a study of over 2.7 million hospital discharges, patients with nasogastric (NG) tubes or percutaneous endoscopic gastrostomy (PEG) had a significantly higher risk of bronchial aspiration and aspiration pneumonia, with odds ratios of 9.1 and 15.2 respectively, compared to those without these feeding devices.

Patients using NG tubes or PEG experienced longer hospital stays (averaging 9.2 and 12.7 more days) and higher diagnostic complexity and costs, indicating that while enteral nutrition is effective, it can lead to serious complications that impact overall healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchopulmonary complications associated to enteral nutrition devices in patients admitted to internal medicine departments. Marco, J., Barba, R., Lázaro, M., et al.[2014]

In a review of 381 radiographs, it was found that only 41% of orogastric and nasogastric feeding tubes in neonates were placed correctly, indicating a high prevalence of improper placements at 59%.

The study highlights the urgent need for improved guidelines and methods to ensure accurate placement of feeding tubes in neonates to enhance safety and effectiveness in enteral feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malposition of feeding tubes in neonates: is it an issue? Quandt, D., Schraner, T., Ulrich Bucher, H., et al.[2022]

Capnography is a highly effective method for confirming the correct placement of nasogastric (NG) tubes, showing 100% sensitivity and 95% accuracy in a study of 60 ICU patients.

In contrast, epigastric auscultation is less reliable, with only 83.4% accuracy, suggesting that capnography should be the preferred method for ensuring safe NG tube placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison of capnography and epigastric auscultation to assess the accuracy of nasogastric tube placement in intensive care unit patients. Heidarzadi, E., Jalali, R., Hemmatpoor, B., et al.[2021]

Training radiographers to interpret nasogastric tube position and using a standardized commenting proforma led to a high adherence rate of 92.9% in following the new safety pathway for tube placement in children.

The accuracy of radiographer comments was 97%, and prompt communication resulted in the safe use of 88.8% of nasogastric tubes, significantly reducing the risk of misplaced tubes and improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate chest radiograph interpretation by radiographers improves patient safety related to nasogastric feeding tube placement in children. Keyte, E., Roe, G., Jeanes, A., et al.[2022]

A survey of 1203 nurses revealed that 76% would use multiple methods to verify nasogastric tube placement, with pH testing being the most common initial method, indicating a cautious approach to patient safety.

Despite the majority taking precautions, there were notable gaps in knowledge regarding the management of gastric residual volume and addressing patient distress during tube feeding, highlighting the need for improved training and updated guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasogastric feeding practices: a survey using clinical scenarios. Chan, EY., Ng, IH., Tan, SL., et al.[2012]

The Dobhoff tube is designed to be more comfortable for patients than traditional nasogastric tubes, making it a popular choice for feeding and medication administration.

However, there are significant risks associated with its insertion, including the rare but serious complication of right-sided hemothorax due to inadvertent tracheobronchial placement, highlighting the need for careful placement techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemothorax Following Traumatic Dobhoff Tube Insertion. Shain, LM., McHale, L., Ahmed, T.[2021]

The Home Enteral Feeding Transitions (HEFT) program successfully increased the utilization of home enteral nutrition (HEN) for infants discharged from the NICU by 10%, indicating a more standardized approach to managing feeding dysfunction in neonates.

Parents reported high satisfaction with HEN (8.6/10), and the program demonstrated safety and effectiveness, with no increase in emergency department visits or admissions related to HEN after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creation of a Standard Model for Tube Feeding at Neonatal Intensive Care Unit Discharge. White, BR., Ermarth, A., Thomas, D., et al.[2021]

A new bedside method for placing nasoenteric feeding tubes was successfully used in 28 out of 31 patients, demonstrating a high success rate of 90.3%.

This technique, which involves gravity, corkscrewing the tube, and air injection for position verification, offers an effective and cost-efficient alternative to more invasive methods like endoscopy or fluoroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedside enteral feeding tube placement into duodenum and jejunum. Thurlow, PM.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11167230/

A Quality Initiative to Prioritize Enteral Feeding in ... Lastly, baseline data on NG tube placement demonstrated a mean percentage of 4.1% of eligible patients with an NG tube placed at admission.

2. publications.aap.org publications.aap.org/hospitalpediatrics/article/12/1/1/183865/Bolus-Versus-Continuous-Nasogastric-Feeds-for

Bolus Versus Continuous Nasogastric Feeds for Infants ... The current study hypothesized that continuous nasogastric feeding would prolong length of stay (LOS) when compared to bolus feeding.

3. bmjopen.bmj.com bmjopen.bmj.com/content/9/5/e025405

Protocol: randomised trial to compare nasoduodenal tube ... As NG tube feeding appears to be well-tolerated in infants with bronchiolitis on HFNC, we hypothesise there will be no difference in duration of respiratory ...

4. scholarlyexchange.childrensmercy.org scholarlyexchange.childrensmercy.org/cgi/viewcontent.cgi?article=1078&context=clinical-critically-appraised-topics

Bronchiolitis: Oral Feeding for Hospitalized Patients Randomized Trial to Compare Nasoduodenal Tube and Nasogastric Tube Feeding in Infants with Bronchiolitis on High-Flow Nasal Cannula. ... NG tube ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5525377/

Quality Improvement Initiative to Increase the Use of ... The goal of our quality improvement (QI) initiative was to increase the rate of NG hydration in eligible children 1 to 23 months old with bronchiolitis by 20% ...

6. publications.aap.org publications.aap.org/hospitalpediatrics/article/12/11/969/189774/Characteristics-and-Outcomes-of-Children

Characteristics and Outcomes of Children Discharged With ... To describe the characteristics and outcomes of children discharged from the hospital with new nasoenteral tube (NET) use after acute hospitalization.

7. uptodate.com uptodate.com/contents/bronchiolitis-in-infants-and-children-treatment-outcome-and-prevention/abstract/36

Medline ® Abstract for Reference 36 of 'Bronchiolitis in infants ... AUTHORS' CONCLUSIONS Based on two RCTs, enteral tube feeding likely results in little to no difference in length of hospital stay compared with ...